The effect of classical foot massage on insomnia and anxiety in preeclamptic pregnant women: a randomized controlled study

SUMMARY OBJECTIVE: Preeclampsia is one of the most common complaints during pregnancy. Preeclamptic pregnant women may experience insomnia and anxiety. METHODS: This study was a randomized controlled trial with 71 preeclamptic women. In the experimental group, a foot massage was done for 3 days in a week. In the control group, any applications were not done. These groups were assessed for insomnia and anxiety levels. RESULTS: In this study, it was found that classical foot massage significantly reduced (12.45±5.74 vs. 33.4±6.41) insomnia and anxiety compared with the control group (18.8±6.44 vs. 39.19±8.31, respectively, p<0.05). CONCLUSION: The classical foot massage can effectively decrease insomnia and anxiety symptoms.


INTRODUCTION
Preeclampsia (PE) is among the critical reasons for maternal morbidity and mortality all over the world 1,2 .In a systematic review of epidemiological studies, the incidence of PE was seen in 0.2-9.2% of pregnancies 3 .While PE makes a healthy pregnancy risky, the expectant mother has to think about a serious disease that threatens both her and the fetus.Accordingly, feelings, such as fear, helplessness, and uncertainty about the progress of pregnancy, may have negative effects on the emotional state of the woman.
Women's sleep is adversely affected by factors such as increased fetal movement with changes in hormone levels and respiratory and cardiovascular system functions during pregnancy, pressure on the bladder from the growing uterus, and nocturia 4 .Multiple sleep disorders in pregnancy manifest themselves as poor sleep quality, insomnia, and sleep-disordered breathing [5][6][7] .In their meta-analysis, Lu et al., found a correlation between general sleep disorders and PE 4 , and that maternal psychosocial deterioration (depression, anxiety, and post-traumatic stress disorder) increased in women with PE 8 .
Pharmacological methods, which are generally used to reduce anxiety and insomnia symptoms, may adversely affect the pregnant woman and the fetus 9 .For this reason, non-invasive, low-cost, and uncomplicated methods should be preferred to reduce anxiety and insomnia that can develop due to PE 10 .Massage improves the sleep quality of the individual by relaxing the muscles and reducing stress and anxiety [11][12][13] .It stimulates cutaneous and subcutaneous sensory receptors, thereby helping venous return and lymphatic flow.It also helps reduce the feeling of pain and remove lactic acid from the muscle fibers, thereby reducing the individual's fatigue and anxiety 14 .Many studies proved that classical foot massage reduces anxiety and insomnia in individuals [13][14][15][16][17][18] .However, there is no study on the application of classical foot massage to reduce anxiety and insomnia symptoms in preeclamptic pregnant women.
This study was planned as a randomized controlled trial to reduce insomnia and anxiety symptoms by applying classical foot massage to pregnant women diagnosed with PE and hospitalized.

METHODS
A prospective, randomized controlled trial design was used.Pregnant women hospitalized in the obstetrics ward of Elazıg Fırat University Hospital between June and December 2022 with a diagnosis of PE and who wanted to participate were included in the study.
Inclusion criteria were as follows: diagnosis of PE, age range of 20-40 years, no diagnosis of a pre-pregnancy sleep disorder or anxiety, having a score of 37 or higher on the state anxiety (STAI-2) scale, and insomnia severity index (ISI) scores of ≥8.
Exclusion criteria were as follows: pregnant women who stayed in the hospital for <3 days, had received treatment for Classical foot massage and preeclamptic pregnant women sleep disorders or anxiety, had a chronic disease except for PE, lost their baby during the study, had a bone deformity on foot, had any obstacles to the massage application as decided by an expert, and were allergic to baby oil, vaseline, or any product.

Randomization
A review of the literature indicated that there was no study on the application of classical foot massage to reduce anxiety and insomnia in preeclamptic pregnant women.However, it was reported by some studies that classical foot massage reduced anxiety and insomnia symptoms 13,[17][18][19][20][21] .The number of subjects to be included in the research was calculated using the G*Power software, and the COHEN standard effect size was assumed as 0.70 22 .Accordingly, the sample size was calculated as at least 68 individuals (α=0.05,1-β=0.80,effect size=0.70, Figure 1) 23 .

Ethics approval
Approval for this study was obtained from the Fırat University Non-Invasive Research Publication and Ethics Board, Fırat University Hospital (Reference number: E-31970446-050.05-187647,Date:03/06/2022) before the data were collected.The study was registered at www.clinicaltrials.govbefore the data collection process was initiated.All procedures were in accordance with the 1964 Helsinki Declaration of Human Rights and its subsequent amendments or comparable ethical standards.The subjects were free to discontinue their participation at any stage.

Participant information form
This questionnaire includes 21 questions about sociodemographic and sleep characteristics during pregnancy.

The insomnia severity index
This seven-item scale was designed to identify the level of insomnia symptoms 24,25 .Boysan et al., conducted the Turkish reliability and validity study of the scale in 2010 26 .Boysan et al., Enrollment found Cronbach's α as 0.79.The alpha value in this study was calculated as 0.79.

The State Anxiety Inventory
This inventory was developed by Spielberger et al 27 .Öner and Compte adapted the scale to Turkish culture and conducted its reliability and validity study 28 .In the Turkish adaptation of the scale, Cronbach's alpha was found to be between 0.83 and 0.92 28 .The alpha value was found as 0.85 in this study.

Data collection
We recruited pregnant women who fulfilled the research criteria and informed them about the research procedures before the application.Accordingly, they knew that they could quit the research when they wanted, and they delivered a consent form.
To prevent bias, a nurse/midwife who worked in the department on the day of data collection and was not included in the research helped participants fill out the participant information form and the ISI and STAI scales.Both the midwife or nurse who helped participants complete the scales and the participants were given information about the study steps.However, they were not informed about the purpose of the massage application, who it would be applied to, and what it would do.Thus, as midwives/nurses other than the researcher who performed the application were blinded, the placebo effect was tried to be minimized by preventing the psychological relief of the women in the study.Participants were randomized to experimental and control groups on a website.These groups were recorded by the researcher in a list.

State Anxiety Inventory, the insomnia severity index, and the participant information form measurement
Participants filled out the questionnaires in 20-25 min during face-to-face interviews.After the 3-day intervention phase, all participants completed a post-intervention ISI and STAI scale by the nurse/midwife who was not included in the research.

Experimental group
Before they went to bed, pregnant women were given a massage for 20 min, including 10 min for each foot, in each session for 3 days in a week (60 min in a week) by using a chronometer 29 .
During the data collection process, all participants were given a massage by the same researcher who had received basic massage education.Participants took a comfortable position and were advised not to speak unless necessary during the massage session.Afterward, they were given a massage with baby oil or vaseline cream.The massage was applied to five parts of the foot, namely, the back of the foot, inner and outer sides, toes, and soles of the feet by using petrissage and effleurage massage techniques.Each massage application to these areas was repeated 3-5 times on average.
In the first stage, the researcher rubbed the soles of the participant's feet before initiating the massage.In the second stage, the researcher made circular movements by applying pressure to the sole of the pregnant woman's feet with her thumb and applied pressure to the foot with up and down movements by using the metacarpophalangeal joints with her hand fisted.In the third stage, the researcher squeezed the participant's heel and ankle between her thumb and forefinger and then gave a massage to the areas by kneading.Then, the massage application was terminated by applying compressions and frictions to each knuckle of the fingers and points between the fingers and between the thumb and forefinger 29 .The researcher who performed the massage obeyed the COVID-19 pandemic measures of the hospital rules during the implementation of the intervention.

Control group
No pharmacological or non-pharmacological method was applied to the participants in this group to reduce their insomnia and anxiety levels.They were treated within the routine hospital protocol.
The post-intervention scores of the experimental and control groups on the ISI and STAI were evaluated.

Data analyses
Data were analyzed using the SPSS software package.Scale scores were found to have a normal distribution by using skewness and kurtosis values 30 .Categorical data were compared using the chi-square test.Data with normal distribution were evaluated with t-tests.Statistical significance was set at p<0.05.

FINDINGS
A total of 71 preeclamptic pregnant women participated in the study, with an age of 34 years and 30.26 weeks gestation.The mean age of the women was 34.5 years in the control group and 34.02 years in the massage group (Table 1).
Table 2 presents the participants in the experimental and control groups on the baseline and post-intervention scores of both ISI and STAI.Participants in the massage group had significantly declined ISI and STAI total scores corrected for post-intervention (p<0.050,Table 2).
Classical foot massage and preeclamptic pregnant women

DISCUSSION
The international and domestic literature was examined, and no studies on the reduction of insomnia and anxiety in preeclamptic pregnant women by using classical foot massage were found.In this study, the effect of classical foot massage applied to pregnant women diagnosed with PE and hospitalized due to insomnia and anxiety symptoms was investigated.Study results were discussed within the framework of the results of other studies on the effect of foot massage applied to groups of women with insomnia and anxiety.These findings are consistent with other studies in which insomnia and anxiety levels are reduced after classical foot massage intervention [19][20][21]31,32 . Classcal foot massage was shown to be effective in decreasing insomnia and anxiety levels.In a randomized controlled trial by Eguchi et al., 52 participants were divided into two groups.In the study, participants the experimental group were given a foot massage for a total of 12 times with 3 sessions in a week for 4 weeks.As a result of the research, it was determined that the anxiety levels of the foot massage group decreased statistically compared with the control group who did not receive the application 20 .Saatsaz et al., conducted a study with 156 primiparous pregnant women and evaluated post-cesarean section

Table 1 .
Comparison of the sociodemographic characteristics of the women participating in the study.