Foot Reflexology on Postpartum Sleep Qualıty
Condition: Postpartum Women
Study type: Interventional

Summary: 
      Aim and objectives: To determine the efficacy of foot reflexology versus standard care for
      improvement of the sleep quality of postpartum women following vaginal birth.

      Background: Sleeplessness is one of the major problems experienced by women in the postpartum
      period following vaginal birth.

      Design: A single-blind, randomized controlled trial was conducted between July 2016 and March
      2017.

      Methods: In this trial, a total of 54 postpartum women were divided into the intervention
      group (n= 24) and control group (n= 30). In the intervention group, four sessions foot
      reflexology was applied for 15 minutes in each foot, every other days between postpartum
      14th- 20th day. Measures included daily and nighttime sleep durations and Postpartum Sleep
      Quality Scale (PSQS) scores. This study was used the CONSORT scheme.
    

Detailed description: 
      This study was a single-blinded, randomized controlled trial with a prospective
      pretest-posttest experimental design. This study was conducted between July 2016 and March
      2017. Postpartum women were visited at their homes following vaginal birth in the obstetrics
      clinic of XXX State Hospital in Turkey.

      To calculate the sample size, we utilized a 95% confidence interval, 80% power, and a 0.8
      effect size. Accordingly, the sample size was determined to be 60 (30 control, 30
      intervention) as calculated a priori with a t test using G Power package software. The study
      was completed with 54 women due to some of the women dropping-out of the study, with 24 women
      in the intervention group and 30 women in the control group. In this study, the simple
      randomization method (Statistical Analysis System Institute, Cary, North Carolina, version
      8.2) was used to create an equal number of samples in both groups. Thus, participants were
      single-blinded to treatment allocation. Also the first researcher delivered the intervention
      and, therefore, could not be blinded to allocation. This study was used the CONSORT scheme.

      A total of four reflexology sessions were applied in the afternoons every other day between
      postpartum days 14 through 20. Pretest data were collected on the 14th day and posttest data
      were collected on the 20th day. This pilot study revealed that no changes were required in
      the study method. The five women who participated in the pilot study were excluded from the
      study data.

      The intervention group was comprised of 30 women in the early postpartum period. Pretest data
      were collected on the 14th day postpartum. Then a total of four reflexology sessions were
      applied for 15 minutes in each foot, in the afternoons, every other day between postpartum
      14th-20th day, as the women were available. And posttest data were collected on the 20th day
      postpartum at the end of the four-reflexology sessions.

      The control group of this study was comprised of 30 women in the early postpartum period who
      had sleep problem and gave vaginal birth. Pretest data were collected on the 14th day
      postpartum. On the 20th day postpartum, the posttest data were assessed during home visits.
      These women only received routine postpartum care from public health nurses but did not
      access the reflexology.

      Data were collected by Personal Information Form and Postpartum Sleep Quality Scale. Data
      were evaluated using SPSS-17 software (Statistical Package for Social Sciences). Descriptive
      data were expressed as score means, standard deviations, and min-max values, and normal
      distribution was measured with kurtosis and skewness. The t test and Mann Whitney U test (z)
      were used to determine the significance of the differences between pretest and posttest sleep
      duration and quality in the control and intervention groups according to the hypotheses.
      Values of p < 0.05 were considered significant. Due to the dropouts in the intervention
      group, an Intention to Treat (ITT) analysis was performed. Mean method was used with the mean
      of the sample followed for missing data. The study data were presented along with the results
      of ITT analysis.

      This study was approved by the Mersin University Ethical Committee of Clinical Research
      (approval number: 4/50, date: 23.02.2016) and by the Ethical Committee of Educational Unit of
      Mersin Public Hospitals Administration. All of the participants provided written informed
      voluntary consent. Participants were informed that their participation was voluntary, that
      they were free to quit the study without providing an excuse, that they could contact the
      researcher by phone as necessary, and that all of the collected data would be kept completely
      confidential and secured.
    

Intervention name(s): foot reflexology
Intervention type(s): Other
Intervention description(s): Four sessions foot reflexology was applied for 15 minutes in each foot, every other days between postpartum 14th- 20th day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Foot reflexology; nursing; postpartum period; postpartum sleep quality