Randomized Controlled Trial Of The Effect Of Foot Reflexology On Sleep Quality Of Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Postpartum Sleep Quality Scale (PSQS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •expression of sleep problem,
- •being literate,
- •being able to communicate in Turkish,
- •aged between 18-45 years old,
- •being in the early postpartum period which lasts 2-6 weeks postpartum
- •having delivered a single fetus with birth weight between 2500 and 4000 grams in the vertex presentation via a vaginal route,
- •currently full breastfeeding
排除标准
- •having experienced complications in the postpartum period (e.g., acute infections and fever states, history of myocardial infarction, irregular blood pressure, epilepsy, diabetes, osteoporosis, deep vein thrombosis, malignant melanoma, eclampsia, and/or preeclampsia),
- •diabetic foot,
- •open wound, varices, edema, or fungal infection in the foot,
- •having been diagnosed with a psychiatric disorder (e.g., postpartum depression, psychosis, etc.), (
- •undergoing pharmacological treatment for sleeplessness,
- •alcohol intake
研究组 & 干预措施
foot reflexology group
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.
干预措施: foot reflexology (Other)
standard care group no reflexology
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
结局指标
主要结局
Postpartum Sleep Quality Scale (PSQS)
时间窗: The prettest data were collected on the 14th day.
The items of the Postpartum Sleep Quality Scale are scored between 0 and 4 on a 5-point Likert scale (0 never, 4 always). Items 1, 2, and 14 are scored in reverse.To calculate the total score, subscale scores are collected. The minimum score of the The Postpartum Sleep Quality Scale is 0, and the maximum available score is 56. Higher PSQS scores indicate worse sleep quality .
sleep durations
时间窗: The prettest data were collected on the 14th day.
Personal Information Form
次要结局
- Postpartum Sleep Quality Scale (PSQS)(The posttest data were collected on the 20th day.)
- sleep durations(The posttest data were collected on the 20th day.)
研究者
Ilkay Arslan
Assoc. Prof. Dr.
Akdeniz University