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The effect of compression stockings on the complaints well-being and sleep quality of pregnant women with restless legs syndrome: a randomized controlled study

SUMMARY

OBJECTIVE:

The aim of this study was to determine the effect of compression stockings on complaints, well-being, and sleep quality in pregnant women with restless legs syndrome.

METHODS:

This randomized placebo-controlled study was conducted on 63 pregnant women (placebo group [PG]=31; experimental group [EG]=32) at the Perinatology Outpatient Clinic of a Health Research and Application Centre in Turkey. Pregnant women in the experimental group wore compression stockings when they got up in the morning for 3 weeks and took them off at bedtime. Placebo group women wore a placebo stocking. Data were collected using the restless legs syndrome Severity Rating Scale, the Pittsburgh Sleep Quality Index, the World Health Organization-5 Well-Being Index, and the Application Satisfaction Form on the 22nd day of the first interview. Statistical significance was accepted as p<0.05.

RESULTS:

Post-test mean scores of both the experimental group and placebo group in the restless legs syndrome Severity Rating Scale (post-test:;8.87±5.27, 12.19±5.60; pre-test:;21.28±5.63, 21.0±5.61; p<0.05), the Pittsburgh Sleep Quality Index (post-test:;5.34±3.28, 6.12±3.12; pre-test:;10.15±4.23, 9.61±4.59; p<0.05), and Well-Being Index (post-test:;18.06±4.59, 19.00±4.47; pre-test:;12.71±5.85, 15.09±5.62; p<0.05) showed recovery according to the pre-tests. However, the post-test restless legs syndrome Severity Rating Scale of the experimental group was lower than that of the placebo group (p<0.05). The effect of their application started in 3.93±1.74 days on average in the experimental group, while it started in 5.09±1.55 days in the placebo group (p<0.05).

CONCLUSION:

Both applications reduced the severity of restless legs syndrome in pregnant women and increased sleep quality and well-being. However, compression stockings were more effective in reducing restless legs syndrome severity. Nurses can use compression and placebo stockings in the care of pregnant women with restless legs syndrome.

Clinical Trial Registration Number:

NCT05795868.

KEYWORDS:
Compression stockings; Obstetric nursing; Restless legs syndrome; Sleep quality; Quality of life

INTRODUCTION

Restless legs syndrome (RLS) is a chronic sensory-motor disorder that causes an irresistible urge to move and discomfort in the legs. Symptoms begin, especially during long-term inactivity, such as sleeping and resting11 Manconi M, Garcia-Borreguero D, Schormair B, Videnovic A, Berger K, Ferri R, et al. Restless legs syndrome. Nat Rev Dis Primers. 2021;7(1):80. https://doi.org/10.1038/s41572-021-00311-z
https://doi.org/10.1038/s41572-021-00311...
. The syndrome is seen twice as often in women22 Holzknecht E, Hochleitner M, Wenning GK, Högl B, Stefani A. Gender differences in clinical, laboratory and polysomnographic features of restless legs syndrome. J Sleep Res. 2020;29(3):e12875. https://doi.org/10.1111/jsr.12875
https://doi.org/10.1111/jsr.12875...
. In addition, RLS is more common in pregnant women compared to other women, and it is seen in 15.4–29.2% of pregnant women in Turkey33 Turan H, Aşkın Turan S, Butun Z, Kayapınar M. The prevalence, severity, and predictive factors of restless legs syndrome in pregnancy. Cureus. 2023;15(9):e44884. https://doi.org/10.7759/cureus.44884
https://doi.org/10.7759/cureus.44884...
,44 Mislu E, Assalfew B, Arage MW, Chane F, Hailu T, Tenaw LA, et al. Prevalence and factors associated with restless legs syndrome among pregnant women in middle-income countries: a systematic review and meta-analysis. Front Med (Lausanne). 2023;10:1326337. https://doi.org/10.3389/fmed.2023.1326337
https://doi.org/10.3389/fmed.2023.132633...
.

It has been stated that genetic factors, the brain dopamine system, and pregnancy-specific factors such as multiparity, hemoglobin, iron and folate deficiency, estrogen level, and nerve tension may be influential in the formation of the syndrome during pregnancy11 Manconi M, Garcia-Borreguero D, Schormair B, Videnovic A, Berger K, Ferri R, et al. Restless legs syndrome. Nat Rev Dis Primers. 2021;7(1):80. https://doi.org/10.1038/s41572-021-00311-z
https://doi.org/10.1038/s41572-021-00311...
,44 Mislu E, Assalfew B, Arage MW, Chane F, Hailu T, Tenaw LA, et al. Prevalence and factors associated with restless legs syndrome among pregnant women in middle-income countries: a systematic review and meta-analysis. Front Med (Lausanne). 2023;10:1326337. https://doi.org/10.3389/fmed.2023.1326337
https://doi.org/10.3389/fmed.2023.132633...
66 Mendes A, Silva V. Possible etiologies of restless legs syndrome in pregnancy: a narrative review. Sleep Sci. 2022;15(4):471-9. https://doi.org/10.5935/1984-0063.20220080
https://doi.org/10.5935/1984-0063.202200...
.

Although RLS is a condition that can be seen in every trimester, its incidence and severity peak in the third trimester77 Darvishi N, Daneshkhah A, Khaledi-Paveh B, Vaisi-Raygani A, Mohammadi M, Salari N, et al. The prevalence of Restless Legs Syndrome/Willis-ekbom disease (RLS/WED) in the third trimester of pregnancy: a systematic review. BMC Neurol. 2020;20(1):132. https://doi.org/10.1186/s12883-020-01709-0
https://doi.org/10.1186/s12883-020-01709...
. It states that as symptoms worsen, there may be significant distress in sleep, well-being, cognitive health, activities of daily living, and social areas of essential functioning55 Picchietti DL, Hensley JG, Bainbridge JL, Lee KA, Manconi M, McGregor JA, et al. Consensus clinical practice guidelines for the diagnosis and treatment of restless legs syndrome/Willis-Ekbom disease during pregnancy and lactation. Sleep Med Rev. 2015;22:64-77. https://doi.org/10.1016/j.smrv.2014.10.009
https://doi.org/10.1016/j.smrv.2014.10.0...
99 Celikgoz D, Pinar G. The effect of sleep disturbance on quality of life in pregnant women. J Nurs Pract. 2021;4(1):293-301. https://doi.org/10.36959/545/397
https://doi.org/10.36959/545/397...
. It was also found that there was an increased rate of pre-eclampsia, difficult labor, cesarean section, and depression in women with RLS. Early treatment is therefore essential for a healthier pregnancy and fetus55 Picchietti DL, Hensley JG, Bainbridge JL, Lee KA, Manconi M, McGregor JA, et al. Consensus clinical practice guidelines for the diagnosis and treatment of restless legs syndrome/Willis-Ekbom disease during pregnancy and lactation. Sleep Med Rev. 2015;22:64-77. https://doi.org/10.1016/j.smrv.2014.10.009
https://doi.org/10.1016/j.smrv.2014.10.0...
,88 Maiolino G, Bisogni V, Soranna D, Pengo MF, Pucci G, Vettor R, et al. Effects of insomnia and restless legs syndrome on sleep arterial blood pressure: a systematic review and meta-analysis. Sleep Med Rev. 2021;59:101497. https://doi.org/10.1016/j.smrv.2021.101497
https://doi.org/10.1016/j.smrv.2021.1014...
1010 Steinweg K, Nippita T, Cistulli PA, Bin YS. Maternal and neonatal outcomes associated with restless legs syndrome in pregnancy: a systematic review. Sleep Med Rev. 2020;54:101359. https://doi.org/10.1016/j.smrv.2020.101359
https://doi.org/10.1016/j.smrv.2020.1013...
.

Nonpharmacological treatments are primarily recommended for RLS. One recommended treatment is to use a pneumatic compression device, proven to work in hemodialysis patients55 Picchietti DL, Hensley JG, Bainbridge JL, Lee KA, Manconi M, McGregor JA, et al. Consensus clinical practice guidelines for the diagnosis and treatment of restless legs syndrome/Willis-Ekbom disease during pregnancy and lactation. Sleep Med Rev. 2015;22:64-77. https://doi.org/10.1016/j.smrv.2014.10.009
https://doi.org/10.1016/j.smrv.2014.10.0...
. RLS symptoms in pregnant women can be relieved by using compression stockings, which can have a similar effect at the same pressure. However, no studies have been found in the literature to report the effectiveness of compression stockings on RLS symptoms. In this context, the aim was to determine the effect of compression stockings on the complaints, well-being, and sleep quality of pregnant women with RLS.

METHODS

Study design

We conducted a randomized, placebo-controlled study (Clinical Trials: NCT05795868).

Settings and samples

This study was conducted in the perinatology outpatient clinic of a university hospital in Turkey. The sample size was determined to be 29 people in each group (differences=1.51; power=0.95; standard deviation=2.5; n2/n1=1)1111 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
. However, 35 pregnant women were included in each group to allow for data that might be lost. Notably, 70 women who met the inclusion criteria were allocated to groups according to pre-prepared randomization lists (fsl 1). Inclusion criteria for the study: the women should be RLS according to the RLS Diagnostic Criteria Questionnaire Form and doctor's examination, symptom severity >10, literate, ages of 18–40 years, with a single pregnancy at 27–37 weeks of gestation, take iron, vitamin D, magnesium, and calcium supplements, and have hemoglobin ≥11 g/dL. The women with communication barriers, high-risk pregnancy, pre-pregnancy RLS, chronic disease, body mass index (BMI) >30, sleep apnea, dermatological problem in the feet and legs, varicose veins, who used antipsychotic, antidepressant, or heparin, antihistamine, antiemetic, calcium channel blocker, dextromethorphan, and decongestant-type drugs were excluded from the study (Figure 1).

Figure 1
Consort flowchart.

Measures

Personal Information Form: The form consists of questions including socio-demographic and obstetric characteristics22 Holzknecht E, Hochleitner M, Wenning GK, Högl B, Stefani A. Gender differences in clinical, laboratory and polysomnographic features of restless legs syndrome. J Sleep Res. 2020;29(3):e12875. https://doi.org/10.1111/jsr.12875
https://doi.org/10.1111/jsr.12875...
77 Darvishi N, Daneshkhah A, Khaledi-Paveh B, Vaisi-Raygani A, Mohammadi M, Salari N, et al. The prevalence of Restless Legs Syndrome/Willis-ekbom disease (RLS/WED) in the third trimester of pregnancy: a systematic review. BMC Neurol. 2020;20(1):132. https://doi.org/10.1186/s12883-020-01709-0
https://doi.org/10.1186/s12883-020-01709...
. The RLS Diagnostic Criteria Questionnaire Form: The International Restless Legs Syndrome Study Group (IRLSSG) created the diagnosis form1212 Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J, et al. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003;4(2):101-19. https://doi.org/10.1016/s1389-9457(03)00010-8
https://doi.org/10.1016/s1389-9457(03)00...
. RLS is diagnosed by answering "yes" to all five questions33 Turan H, Aşkın Turan S, Butun Z, Kayapınar M. The prevalence, severity, and predictive factors of restless legs syndrome in pregnancy. Cureus. 2023;15(9):e44884. https://doi.org/10.7759/cureus.44884
https://doi.org/10.7759/cureus.44884...
,99 Celikgoz D, Pinar G. The effect of sleep disturbance on quality of life in pregnant women. J Nurs Pract. 2021;4(1):293-301. https://doi.org/10.36959/545/397
https://doi.org/10.36959/545/397...
.

Restless legs syndrome Severity Rating Scale: The scale was developed by IRLSSG and consists of 10 questions1313 Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, et al. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003;4(2):121-32. https://doi.org/10.1016/s1389-9457(02)00258-7
https://doi.org/10.1016/s1389-9457(02)00...
. The score range varies between 0 and 40. A score of 1–10 indicates mild, a score of 11–20 indicates moderate, a score of 21–30 indicates severe, and a score of 31–40 indicates very severe. The validity and reliability study of the scale was conducted in Turkey1414 Ay E, Helvacı Yılmaz N, Arıcı Düz Ö, Özer FF. Validity and reliability of the Turkish version of the International Restless Legs Syndrome Study Group rating scale. Acta Med Alanya. 2019;3:104-9. https://doi.org/10.30565/medalanya.453150
https://doi.org/10.30565/medalanya.45315...
. In this study, Cronbach's alpha coefficient was 0.79–0.90.

Pittsburgh Sleep Quality Index (PSQI): PSQI was developed in 1989 by Buyyse et al.1515 Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193-213. https://doi.org/10.1016/0165-1781(89)90047-4
https://doi.org/10.1016/0165-1781(89)900...
It evaluates sleep quality. The PSQI consists of 24 questions. The total PSQI score ranges from 0 to 21. Scores greater than 5 indicate poor sleep quality. The validity and reliability study was conducted by Ağargün et al in Turkey1616 Ağargün MY, Kara H, Anlar Ö. The validity and reliability of the Pittsburgh Sleep Quality Index. Turk J Psychiatry. 1996;7(2):107-15.. In this study, Cronbach's alpha coefficient was found to be 0.76–0.79.

World Health Organization-5 Well-Being Index (WHO-5): The WHO-5 questionnaire comprises five items related to the participant's feelings. Each item is evaluated between 0 and 5. The total score ranges from 0 to 25. A total score below 13 indicates a poor quality of life1717 Mortazavi F, Mousavi SA, Chaman R, Khosravi A. Validation of the World Health Organization-5 Well-Being Index; assessment of maternal well-being and its associated factors. Turk Psikiyatri Derg. 2015;26(1):48-55. PMID: 25742037. The validity and reliability study of the scale was conducted in Turkey1818 Eser E, Çevik C, Baydur H, Güneş S, Esgin TA, Öztekin ÇS, et al. Reliability and validity of the Turkish version of the WHO-5, in adults and older adults for its use in primary care settings. Prim Health Care Res Dev. 2019;20:e100. https://doi.org/10.1017/S1463423619000343
https://doi.org/10.1017/S146342361900034...
. In this study, Cronbach's alpha coefficient was found to be 0.87–0.88.

Application Satisfaction Form: The researcher created the form to determine the participants’ satisfaction levels toward the application. Satisfaction levels consist of two parts: positive and negative feedback about the application is expressed numerically on a decimal scale and is open-ended.

Procedures

The data collection instruments were administered to pregnant women in a face-to-face interview with the researcher. Data were collected in outpatient clinics and it took approximately 20–25 min to complete the questionnaires. The Personal Information Form, IRLSSG, PSQI, and WHO-5 forms were administered to all of the pregnant women as a pre-test. For 3 weeks, the women in the groups wore the socks they were given before. The women were administered the IRLSSG, PSQI, WHO-5, and a follow-up form at the end of 3 weeks.

Experimental group intervention

The experimental group (EG) used CCL2 (below-knee medium pressure) stockings (23–32 mm/Hg) with a graduated pressure system and size variation. The size of compression stockings suitable for pregnant women was determined, and stockings were provided. Women in groups were taught how to wear the stockings and were given written instructions. For 3 weeks, the women in the groups wore the socks they were given before getting up in the morning at home and took them off when they slept.

Placebo group intervention

The placebo group (PG) used 100-denier knee-high stockings with no therapeutic effect. Women in groups were taught how to wear the stockings and were given written instructions. For 3 weeks, the women in the groups wore the socks they were given before getting up in the morning at home and took them off when they slept.

Statistical analyses

The data were analyzed using SPSS 24.0, and values p<0.05 were accepted. The normality of the data of the numerical variables was evaluated with the QQ plot, the kurtosis, and skewness measures. Homogeneity between groups was analyzed by t-test. Due to the normal distribution of the data, the independent sample t-test was used in the independent groups, and the dependent-sample t-test was used in the dependent groups. Descriptive analysis was used in cases that expressed feedback about the application.

Ethical aspect of the study

Approval (2020/627) to conduct the study was obtained from the Clinical Research Ethics Committee, and the Helsinki Declaration ethical principles were followed at all stages. Informed voluntary written consent was obtained from those included in the study.

RESULTS

The groups were similar in terms of socio-demographic and obstetric characteristics (p>0.05; Table 1).

Table 1
Comparison of socio-demographic and obstetric characteristics by groups.

The IRLSSG pre-test mean scores of the EG and PG were similar (21.28±5.63 and 21.0±5.61, respectively; p>0.05). The post-test mean score of the EG (8.87±5.27) was lower than the PG (12.19±5.60) (p<0.05). However, the IRLSSG post-test mean score of both groups was statistically significantly lower than the pre-test mean scores of the groups (p<0.001; Table 2).

Table 2
Comparison of the pre-test and post-test mean scores of the scales according to the groups.

The PSQI pre-test scores of the groups were similar (p>0.05). Although the mean post-test PSQI score was smaller in the EG (5.34±3.28) than in the PG (6.12±3.12), this difference was not statistically significant (p>0.05; Table 2).

The groups were similar in terms of WHO-5 pre-test scores and post-test scores (p>0.05). The mean post-test WHO-5 score was similar in the EG (18.06±4.59) and PG (19.00±4.47) groups (p>0.05; Table 2). Women in the EG reported that they experienced relief, on average, 3.93±1.74 days after application, while women in the PG reported that they experienced relief, 5.09±1.55 days after application (p<0.05; Table 2).

The most common positive and negative codes in the EG were pain relief/reduction (n=13) and discomfort (n=14). For PG, the most commonly reported positive and negative codes were pain relief/reduction (n=15) and sweaty legs (n=4) (Table 3).

Table 3
Distribution of positive and negative statements of pregnant women in the experimental group and placebo group (n=32)* * One participant is listed under more than one code. P: participant. .

DISCUSSION

In the study, the severity of RLS decreased to a mild level in the EG after application, while it decreased to a moderate level in the PG. Although improvements in the severity of RLS were observed in both groups, this effect was greater in the EG. There is evidence that the compression device and enhanced external counterpulsation (EECP), which have a similar effect on the venous system, may be effective in groups other than pregnancy1111 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
,1919 Eliasson AH, Lettieri CJ. Sequential compression devices for treatment of restless legs syndrome. Medicine (Baltimore). 2007;86(6):317-23. https://doi.org/10.1097/MD.0b013e31815b1319
https://doi.org/10.1097/MD.0b013e31815b1...
. A study of 10 people found that using a pneumatic compression device for 1 h in the evening could relieve RLS symptoms and improve their quality of life2020 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
. In another randomized, placebo-controlled trial, people with RLS were given 1 h of therapeutic or placebo compression per day. The study found a beneficial effect of placebo compression. At the same time, therapeutic compression was found to improve the severity of the disease compared to placebo1111 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
. In their pilot study, Rajaram et al. 1919 Eliasson AH, Lettieri CJ. Sequential compression devices for treatment of restless legs syndrome. Medicine (Baltimore). 2007;86(6):317-23. https://doi.org/10.1097/MD.0b013e31815b1319
https://doi.org/10.1097/MD.0b013e31815b1...
found that enhanced EECP for 35 days significantly improved RLS symptoms in six patients with RLS. These investigators then conducted a randomized, double-blind, and sham-controlled study of EECP in RLS patients. The study was completed with six people and found that although both groups experienced an improvement in RLS severity scores, this could not be statistically evaluated2121 Rajaram SS, Shanahan J, Ash C, Walters AS, Weisfogel G. Enhanced external counter pulsation (EECP) as a novel treatment for restless legs syndrome (RLS): a preliminary test of the vascular neurologic hypothesis for RLS. Sleep Med. 2005;6(2):101-6. https://doi.org/10.1016/j.sleep.2004.10.012
https://doi.org/10.1016/j.sleep.2004.10....
. Based on the results of this study, it is suggested that pneumatic compression can be used to reduce the severity of RLS symptoms during pregnancy and that the placebo effect should be investigated55 Picchietti DL, Hensley JG, Bainbridge JL, Lee KA, Manconi M, McGregor JA, et al. Consensus clinical practice guidelines for the diagnosis and treatment of restless legs syndrome/Willis-Ekbom disease during pregnancy and lactation. Sleep Med Rev. 2015;22:64-77. https://doi.org/10.1016/j.smrv.2014.10.009
https://doi.org/10.1016/j.smrv.2014.10.0...
. In this context, the findings obtained in the study are similar to those found in the literature1919 Eliasson AH, Lettieri CJ. Sequential compression devices for treatment of restless legs syndrome. Medicine (Baltimore). 2007;86(6):317-23. https://doi.org/10.1097/MD.0b013e31815b1319
https://doi.org/10.1097/MD.0b013e31815b1...
,2020 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
. The fact that compression stockings reduce the severity of RLS supports the theory that RLS may be associated with venous insufficiency1919 Eliasson AH, Lettieri CJ. Sequential compression devices for treatment of restless legs syndrome. Medicine (Baltimore). 2007;86(6):317-23. https://doi.org/10.1097/MD.0b013e31815b1319
https://doi.org/10.1097/MD.0b013e31815b1...
,2020 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
,2222 Rajaram SS, Rudzinskiy P, Walters AS. Enhanced external counter pulsation (EECP) for restless legs syndrome (RLS): preliminary negative results in a parallel double-blind study. Sleep Med. 2006;7(4):390-1. https://doi.org/10.1016/j.sleep.2006.03.008
https://doi.org/10.1016/j.sleep.2006.03....
,2323 McDonagh B, King T, Guptan RC. Restless legs syndrome in patients with chronic venous disorders: an untold story. Phlebology. 2007;22(4):156-63. https://doi.org/10.1258/026835507781477145
https://doi.org/10.1258/0268355077814771...
. Pneumatic compression devices, compression stockings, and EECP are thought to reduce the sensory symptoms of RLS by affecting the peripheral or central nervous system by regulating vascular flow. The significant effect of the placebo socks is similar to that found in the literature and shows that psychological factors can affect the severity of RLS1111 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
,2020 Lettieri CJ, Eliasson AH. Pneumatic compression devices are an effective therapy for restless legs syndrome: a prospective, randomized, double-blinded, sham-controlled trial. Chest. 2009;135(1):74-80. https://doi.org/10.1378/chest.08-1665
https://doi.org/10.1378/chest.08-1665...
.

The negative impact on sleep disturbance and quality of life in patients with RLS generally varies in direct proportion to the severity of the disease66 Mendes A, Silva V. Possible etiologies of restless legs syndrome in pregnancy: a narrative review. Sleep Sci. 2022;15(4):471-9. https://doi.org/10.5935/1984-0063.20220080
https://doi.org/10.5935/1984-0063.202200...
,88 Maiolino G, Bisogni V, Soranna D, Pengo MF, Pucci G, Vettor R, et al. Effects of insomnia and restless legs syndrome on sleep arterial blood pressure: a systematic review and meta-analysis. Sleep Med Rev. 2021;59:101497. https://doi.org/10.1016/j.smrv.2021.101497
https://doi.org/10.1016/j.smrv.2021.1014...
,99 Celikgoz D, Pinar G. The effect of sleep disturbance on quality of life in pregnant women. J Nurs Pract. 2021;4(1):293-301. https://doi.org/10.36959/545/397
https://doi.org/10.36959/545/397...
. This study, like others, found that pregnant women in the groups experienced severe symptoms and had impaired sleep and quality of life. However, after the applications, the severity of RLS decreased in both groups, and there were similar improvements in sleep quality and quality of life. In a randomized, placebo-controlled study, positive effects of therapeutic or placebo compression applied to people with RLS were observed in both groups. However, in contrast to our study, therapeutic compression was found to improve daytime sleepiness, fatigue measures, and quality of life compared to placebo1717 Mortazavi F, Mousavi SA, Chaman R, Khosravi A. Validation of the World Health Organization-5 Well-Being Index; assessment of maternal well-being and its associated factors. Turk Psikiyatri Derg. 2015;26(1):48-55. PMID: 25742037. Another study evaluated polysomnographic measurements in six patients with RLS after EECP (four people) or placebo (two people) treatment and concluded that although there was a reduction in RLS severity, there was no significant effect on sleep2121 Rajaram SS, Shanahan J, Ash C, Walters AS, Weisfogel G. Enhanced external counter pulsation (EECP) as a novel treatment for restless legs syndrome (RLS): a preliminary test of the vascular neurologic hypothesis for RLS. Sleep Med. 2005;6(2):101-6. https://doi.org/10.1016/j.sleep.2004.10.012
https://doi.org/10.1016/j.sleep.2004.10....
.

The reduction of RLS severity and symptoms during pregnancy is very important. However, characteristics such as time to start, ease of use, satisfaction, and positive or negative aspects of the effectiveness of the application should also be identified. This study reported that almost all pregnant women in both the intervention and placebo groups benefited from the application, with the effect of the application starting on average from day 4 in the intervention group and from day 5 in the placebo group. Satisfaction with the treatment was similar in both groups. Reduction/relief of leg pain was reported as a positive feature of the applications in both groups. However, there were more negative reports about the use of compression stockings. However, the reported negative effects were more related to discomfort due to the tightness of the stockings or the enlargement of the abdomen than to health problems.

Strengths and limitations of the study

This research is one of the limited studies conducted to reduce the severity of symptoms in pregnant women with RLS. It is also the first study in the literature to investigate the effectiveness of compression stockings in reducing the severity of RLS. The results suggest that applying compression and placebo stockings may effectively reduce RLS symptoms and improve sleep and quality of life. In addition, how long the applications took effect and the women's opinions about the applications were also questioned. Another strength of this study is that compression and placebo stockings are cost-effective and easy to obtain. In addition, there is no need for hospitalization since technical knowledge and personnel are not needed for its use. Since people will not have to spend additional time or effort using socks, they can continue their daily activities. The limitation of the study is that the results were based on self-report rather than objective measurement.

CONCLUSION

The study found that wearing compression stockings and placebo stockings reduced the severity of RLS in pregnant women and improved their sleep and quality of life. The effect of the stockings was felt within 3–5 days, and the women were satisfied with the stockings and did not report any serious complications. In this context, health professionals, especially nurses, should develop institutional policies to reduce the severity of symptoms in pregnant women with RLS and develop solutions, including the use of compression stockings.

  • Funding:

    the Scientific and Technological Research Council of Türkiye 1002 program supported this study with project number 221S452.

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Publication Dates

  • Publication in this collection
    16 Aug 2024
  • Date of issue
    2024

History

  • Received
    05 Mar 2024
  • Accepted
    24 Mar 2024
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