Foot Reflexology on Postpartum Sleep Qualıty

NCT03882086 | Completed

• 1 other identifier: 01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postpartum Women

Keywords

Foot reflexology; nursing; postpartum period; postpartum sleep quality

Outcome Measures

Primary Outcomes (2)

• Postpartum Sleep Quality Scale (PSQS)

  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 .

  The prettest data were collected on the 14th day.

• sleep durations

  Personal Information Form

  The prettest data were collected on the 14th day.

Secondary Outcomes (2)

• 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.

Study Arms (2)

foot reflexology group

EXPERIMENTAL

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.

Other: foot reflexology

standard care group no reflexology

NO INTERVENTION

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

Interventions

foot reflexology OTHER

Four sessions foot reflexology was applied for 15 minutes in each foot, every other days between postpartum 14th- 20th day

foot reflexology group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Officials

• Nida SELVİ

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Study Record Dates

• First Submitted: March 10, 2019
• First Posted: March 20, 2019
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share