NCT07432074

Brief Summary

Cesarean section births have rapidly increased both in our country and worldwide in recent years. According to OECD data, one in four births worldwide and one in two births in our country is a cesarean section. The cesarean section has become one of the most frequently performed surgical interventions. The incision from a cesarean section causes pain, mobilization issues, and delays in mother-infant interaction. The choice of pharmacological methods used after a cesarean section is often limited by concerns about the baby and breastfeeding, leading to inadequate pain management and causing women to experience moderate to high levels of pain. Pain negatively affects individuals' comfort, leading to sleep disturbances, fatigue, and a decreased quality of life. It makes daily activities and responsibilities as individuals more challenging to manage. There is a need for nurses, in their primary caregiver role, to adopt a multidisciplinary approach to pain management and to develop their skills in using non-pharmacological methods. These methods should be clinically applied and proven effective. Acupressure and massage are long-standing, cost-effective, easy-to-apply, and effective methods used to reduce pain. This study aims to reduce pain and fatigue and improve sleep quality in women who have undergone a cesarean section by applying acupressure and massage in the postoperative period, thereby preventing the chronicization of these problems.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

February 10, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 10, 2026

Last Update Submit

February 24, 2026

Conditions

Pain ManagementSleep QualityMassage EffectAcupressureFatigue

Keywords

Acupressurecesarean sectionback massagepainfatiguesleep quality

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale for Pain

    Pain intensity was assessed using the Visual Analog Scale for Pain (VAS), a 10-cm horizontal line ranging from 0 to 10, where: * 0 = no pain * 10 = unbearable pain

    Periprocedural (immediately after the intervention or standard care)

Secondary Outcomes (2)

  • Postpartum Sleep Quality Scale

    15 minutes after completion of the intervention

  • Postnatal Accumulated Fatigue Scale

    15 minutes after completion of the intervention

Other Outcomes (2)

  • PERSONAL INFORMATION FORM

    Baseline (prior to intervention)

  • Intervention Satisfaction Form

    15 minutes post-intervention

Study Arms (3)

Acupressure

EXPERIMENTAL
Other: Acupressure to points HT7, LI4, SP6 and ST36

Massage

EXPERIMENTAL
Other: Massage

Control

NO INTERVENTION

Interventions

Acupressure to points HT7, LI4, SP6 and ST36OTHER

This point specialized for pain management, fatigue and sleep

Acupressure
MassageOTHER

back massage

Massage

Eligibility Criteria

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

You may qualify if:

  • Women aged 18-45 years
  • Undergoing cesarean delivery under spinal anesthesia,
  • Having a term, single, and healthy newborn,
  • Gestational age of 37-40 weeks,
  • No communication difficulties,
  • No systemic or chronic diseases,
  • Willing to participate in the study.

You may not qualify if:

  • Undergoing cesarean delivery under general or epidural anesthesia,
  • Development of any maternal or neonatal complications during the postpartum period (hypertension, hemorrhage, infants requiring intensive care, etc.),
  • Having chronic fatigue or pain problems,
  • Using caffeine (tea, coffee, chocolate, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaSleep Initiation and Maintenance DisordersFatiguePain

Interventions

arginyl-threonyl-prolyl-prolyl-prolyl-seryl-glycineMassage

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Two intervention, one control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 25, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

TU(1)