NCT07867561

Brief Summary

This randomized controlled trial evaluated the effects of back massage applied after elective cesarean birth on postpartum fatigue and maternity blues. Women were randomly assigned to either a back massage group or a control group. The intervention group received a 30-minute back massage after the first postoperative mobilization, while the control group received routine postpartum care only. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

October 2, 2026

Last Update Submit

October 6, 2026

Conditions

Keywords

Back MassageCesarean BirthPostpartum FatigueMaternity BluesPostpartum CareNonpharmacological Intervention

Outcome Measures

Primary Outcomes (2)

  • Postpartum Fatigue Assessed by the Postnatal Accumulated Fatigue Scale

    The Postnatal Accumulated Fatigue Scale consists of 13 items and three subscales. Total scores range from 0 to 39, with higher scores indicating greater postpartum fatigue.

    48 hours after cesarean birth

  • Maternity Blues Assessed by the Maternity Blues Scale

    The Turkish version of the Maternity Blues Scale consists of 28 items and five subscales. Higher scores indicate higher levels of maternity blues.

    48 hours after cesarean birth

Study Arms (2)

Back Massage Group

EXPERIMENTAL

Participants assigned to the Back Massage Group received routine postpartum care plus a 30-minute back massage. The massage was administered after the first mobilization at the sixth postoperative hour following elective cesarean birth. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge.

Behavioral: Back Massage

Control Group

NO INTERVENTION

Participants assigned to the Control Group received the hospital's routine postpartum care only and did not receive any additional intervention. Postpartum fatigue and maternity blues were assessed on the second postoperative day before discharge.

Interventions

Back MassageBEHAVIORAL

Participants in the Back Massage Group received a 30-minute back massage in addition to routine postpartum care. The massage was administered after the first mobilization at the sixth postoperative hour following elective cesarean birth. The intervention was delivered by the second researcher. Participants continued to receive the hospital's standard postpartum care throughout the study.

Back Massage Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who underwent elective cesarean birth
  • Women with a single healthy newborn
  • Women who did not have a negative response to massage or touch interventions
  • Women with intact skin and tissue integrity in the back area where the massage was applied

You may not qualify if:

  • Women with communication problems
  • Women who underwent cesarean birth under general anesthesia
  • Women diagnosed during pregnancy or birth with complications such as oligohydramnios, preeclampsia, heart disease, diabetes, or placenta previa
  • Women who developed postpartum complications such as hemorrhage or hypertension
  • Women whose newborn required admission to the neonatal intensive care unit
  • Women who received additional analgesic or narcotic medication other than the routine postoperative analgesic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Study Officials

  • Sena Dilek Aksoy, Ph.D.

    Kocaeli University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Due to the nature of the intervention, participants and the researcher who administered the back massage could not be blinded. Outcome assessments were performed by a third researcher who was blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups: the back massage group or the control group. Participants in the back massage group received a 30-minute back massage in addition to routine postpartum care, while participants in the control group received routine postpartum care only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Midwifery

Study Record Dates

First Submitted

October 2, 2026

First Posted

October 9, 2026

Study Start

May 10, 2025

Primary Completion

May 10, 2026

Study Completion

May 10, 2026

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations