NCT06769958

Brief Summary

This study was conducted to determine the effects of reflexology applied to mothers with headache due to spinal anesthesia after Cesarean delivery on pain, comfort and breastfeeding self-efficacy levels. The study, which was conducted with a single-blind, randomized controlled experimental design, was conducted between April 2024 and August 2024 at the Department of Obstetrics and Pediatrics, SBU Van Training and Research Hospital with mothers who had cesarean delivery under spinal anesthesia and had postpartum headache (Intervention group=30, Control group=30). Foot reflexology was applied to the mothers in the intervention group for a total of 30 minutes, 15 minutes on each foot. The control group was not subjected to any intervention other than routine nursing practices. Personal Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale (PPSC) and Breastfeeding Self-Efficacy Scale (BSSE) were used as data collection tools.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

December 31, 2024

Last Update Submit

January 7, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    min-max (0-10), an increased score is a bad result

    pre-test post-test (approximately eight months), reduce pain

  • Postpartum Comfort Scale

    min-max (34-170), increased score is a good result

    pre-test post-test (approximately eight months), Increasing Postpartum Comfort

  • Breastfeeding Self-Efficacy Scale

    min-max (14-70), increased score is a good result

    pre-test post-test (approximately eight months), Increasing breastfeeding self-efficacy

Study Arms (2)

Reflexology

EXPERIMENTAL
Behavioral: Reflexology

Control

NO INTERVENTION

Interventions

ReflexologyBEHAVIORAL

Reflexology application

Reflexology

Eligibility Criteria

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

You may qualify if:

  • years and older,
  • performing SD under spinal anesthesia,
  • experiencing postpartum headaches,
  • Caesarean section performed at 37-42 weeks of gestation,
  • giving only one live birth,
  • open to written or oral communication,
  • at least a primary school graduate,
  • no complications during pregnancy,
  • mothers who agreed to participate in the study

You may not qualify if:

  • Performing a cesarean section at periods other than 37-42 weeks of gestation,
  • caesarean section under general anesthesia,
  • have health problems such as fractures, dislocations, phlebitis, arthritis, burns, wounds, eczema, fungus or inflammation in the foot tissue,
  • with disease of the cardiovascular system,
  • with chronic diseases such as hypertension or diabetes mellitus,
  • Postpartum controlled analgesia administered,
  • mothers with psychiatric diagnoses such as anxiety and depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, Tuşba, 65000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 10, 2025

Study Start

January 1, 2024

Primary Completion

August 20, 2024

Study Completion

August 30, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations