- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05521581
Effects Of Hand Massage After Cesarean Section
THE EFFECT OF AFTER CAESARIAN SECTION HAND MASSAGE ON PAIN, COMFORT LEVEL AND GAS OUTPUT TIME
H1-1 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the level of pain in the cesarean section incision area of women.
H1-2 Hypothesis: Hand massage applied after cesarean delivery has an effect on increasing the comfort scale score of women.
H1-3 Hypothesis: Hand massage applied after cesarean delivery has an effect on reducing the time of gas production in women.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kırıkkale, Turkey, 71100
- Sinem Dügeroğlu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Having primiparous pregnancy,
- 18 years old and over,
- Able to speak Turkish and express himself in Turkish,
- Does not have any disability (such as vision, hearing)
- Having completed the 6th hour after cesarean delivery, hospitalized in the gynecology service,
- Having undergone cesarean section with spinal anesthesia,
- Having no findings such as wounds, nerve problems, history of surgery or amputation on their hands,
- Single pregnancy,
- Women who are open to communication and who are mentally and physically healty
Exclusion Criteria:
Not accepting to work,
- Having a gas outlet before starting the application,
- Presence of findings such as wounds on hands, nerve problems, history of surgery or amputation,
- Having postpartum hemorrhage,
- With uterine subinvolution,
- Having a cesarean section with another type of anesthesia other than spinal anesthesia (such as general, epidural combined)
- Having twin babies,
- Having a premature baby (the baby needs more attention and care)
- Women whose babies are hospitalized in the neonatal intensive care unit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention
Hand massage will be applied to primiparous mothers who gave birth by cesarean section
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Hand massage will be applied to primiparous mothers who gave birth by cesarean section and its effect on pain, comfort and gas release times will be evaluated.
|
|
No Intervention: control
Routine care will be given to mothers who have given cesarean section and hand massage will not be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
inclusion of women in the study and filling out the introductory information form
Time Frame: maximum one hour
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Women are included in the study by filling out the introductory information form.
The information obtained will be recorded in the SPSS 20.0 package program.
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maximum one hour
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ensuring the randomization of the women included in the study into the intervention and control groups
Time Frame: Five min
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Distributions are made to women included in the study and to control and intervention groups.
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Five min
|
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practicing and observing hand massage
Time Frame: an average of 12-13 hours
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Mothers assigned to the intervention group receive 2 sessions of hand massage. The first session is applied at the 6th hour after the cesarean section, and the second session is applied at the 12th hour after the cesarean section. Routine care is applied to the control group and hand massage is not applied. |
an average of 12-13 hours
|
|
assessment of pain
Time Frame: five min
|
Women in the intervention and control groups are assessed for pain with the Visual Analog Scale (VAS).
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five min
|
|
comfort assessment
Time Frame: ten min
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Women in the intervention and control groups will be evaluated with the Postpartum Comfort Scale.
|
ten min
|
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Evaluation of gas exit time
Time Frame: five min
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The effectiveness of hand massage will be evaluated by looking at the time between cesarean section hours and gas release times of women in the intervention and control groups.
|
five min
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SelcukU SDugeroglu071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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