- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06769958
The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy
January 7, 2025 updated by: Veysel Can, Yuzuncu Yıl University
The Effect of Reflexology on Pain, Comfort and Breastfeeding Self-Efficacy in Post-Cesarean Headache Due to Spinal Anesthesia
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tuşba
-
VAN, Tuşba, Turkey, 65000
- Van Yuzuncu Yıl University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Reflexology
|
Reflexology application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: pre-test post-test (approximately eight months), reduce pain
|
min-max (0-10), an increased score is a bad result
|
pre-test post-test (approximately eight months), reduce pain
|
|
Postpartum Comfort Scale
Time Frame: pre-test post-test (approximately eight months), Increasing Postpartum Comfort
|
min-max (34-170), increased score is a good result
|
pre-test post-test (approximately eight months), Increasing Postpartum Comfort
|
|
Breastfeeding Self-Efficacy Scale
Time Frame: pre-test post-test (approximately eight months), Increasing breastfeeding self-efficacy
|
min-max (14-70), increased score is a good result
|
pre-test post-test (approximately eight months), Increasing breastfeeding self-efficacy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
August 20, 2024
Study Completion (Actual)
August 30, 2024
Study Registration Dates
First Submitted
December 31, 2024
First Submitted That Met QC Criteria
January 7, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 7, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Reflexology
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Reflexology
-
Hillel Yaffe Medical CenterUnknown
-
Mansoura UniversityNot yet recruiting
-
Wolfson Medical CenterNot yet recruitingLabor Induction | Reflexology | Extra Amniotic Balloon
-
Selcuk UniversityCompletedNursing Caries | Breastfeeding | Postpartum | Reflexology | Lactation Failure
-
Sanko UniversityCompletedFatigue | Renal Transplantation | Nursing | ReflexologyTurkey
-
Dokuz Eylul UniversityCompletedPain | Hemodynamic Instability | Massage | Endotracheal Aspiration | ReflexologyTurkey
-
Cairo UniversityCompletedDietary Modification | Reflexology
-
Akdeniz UniversityCompletedInfantile Colic | Reflexology
-
Istanbul University - CerrahpasaRecruitingColorectal Surgery | Nursing | Reflexology | Traditional Chinese Medication (TCM)Turkey
Clinical Trials on Reflexology
-
Bnai Zion Medical CenterCompletedPain | Nausea | AnxietyIsrael
-
Bartın UnıversityCompletedPain | Abdominal Pain | Sleep Quality | Nursing | Appendectomy | Reflexology | Bowel FunctionsTurkey
-
Cairo UniversityNot yet recruiting
-
Meir Medical CenterClalit Health Services; Reidman collegeUnknown
-
Saglik Bilimleri UniversitesiCompletedBurn Degree Second | Burn Degree ThirdTurkey
-
Dicle UniversityCompletedHealthy | Nursing CariesTurkey
-
Shaare Zedek Medical CenterUnknown
-
Baskent UniversityCompletedPeripheral Arterial DiseaseTurkey
-
Sanko UniversityCompletedFatigue | Renal Transplantation | Nursing | ReflexologyTurkey
-
Hillel Yaffe Medical CenterCompletedReflexology | Bronchiolitis; ChemicalIsrael