The Effects of Acupressure and Massage Following Cesarean Section
The Effects of Acupressure and Back Massage on Pain, Fatigue, and Sleep Quality in Cesarean Sections: A Randomized Controlled Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Marmara University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Massage
|
back massage
|
|
Experimental: Acupressure
|
This point specialized for pain management, fatigue and sleep
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale for Pain
Time Frame: Periprocedural (immediately after the intervention or standard care)
|
Pain intensity was assessed using the Visual Analog Scale for Pain (VAS), a 10-cm horizontal line ranging from 0 to 10, where:
|
Periprocedural (immediately after the intervention or standard care)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Sleep Quality Scale
Time Frame: 15 minutes after completion of the intervention
|
Sleep quality was measured using the Postpartum Sleep Quality Scale, a 14-item questionnaire scored on a 5-point Likert scale (0 = Never to 4 = Always).
Total scores range from 0 to 56, with higher scores indicating poorer sleep quality (worse outcome).
The scale has no cut-off value.
Assessments were performed before and after the intervention.
|
15 minutes after completion of the intervention
|
|
Postnatal Accumulated Fatigue Scale
Time Frame: 15 minutes after completion of the intervention
|
Fatigue was assessed using the Postnatal Accumulated Fatigue Scale, a 13-item questionnaire comprising three subdomains (physical fatigue, emotional fatigue, and cognitive fatigue).
Each item is scored as 0 = Almost none, 1 = Sometimes, and 3 = Mostly/Often.
Total scores range from 0 to 39, with higher scores indicating greater fatigue (worse outcome).
The scale has no cut-off value.
Assessments were performed before and after the intervention.
|
15 minutes after completion of the intervention
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PERSONAL INFORMATION FORM
Time Frame: Baseline (prior to intervention)
|
Baseline demographic and obstetric characteristics were collected using a Personal Information Form administered once prior to the intervention.
|
Baseline (prior to intervention)
|
|
Intervention Satisfaction Form
Time Frame: 15 minutes post-intervention
|
Satisfaction with the intervention was assessed using the Intervention Satisfaction Form, a Visual Analog Scale-based measure ranging from 0 to 10, where:
Higher scores indicate greater satisfaction (better outcome). |
15 minutes post-intervention
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Fatigue
- Sleep Initiation and Maintenance Disorders
- Agnosia
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
- arginyl-threonyl-prolyl-prolyl-prolyl-seryl-glycine
Other Study ID Numbers
Other Study ID Numbers
- marmaradeneysel
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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