- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421233
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kayseri
-
Kocasinan, Kayseri, Turkey
- Kayseri City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Giving birth vaginally at term,
- Postpartum within 24 hours,
- Primiparous,
- Those who are healthy and have given birth to a single baby,
- Postpartum women who volunteered to participate in the study were included.
Exclusion Criteria:
- Those with psychiatric illness (Bipolar Disorder, Depression, Obsessive Compulsive Disorder),
- People with chronic diseases (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD,
- Those who have been diagnosed with a risky pregnancy (Pre-eclampsia, Arthritis, Pregnancy-related hypertension, Gestational diabetes),
- Whose baby was admitted to neonatal intensive care,
- Postpartum women with postpartum bleeding were not included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
Endorphin massage will be given for 15 minutes every 2 hours.
Other Names:
|
|
No Intervention: Control gruop
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State and Trait Anxiety Scale
Time Frame: It was applied twice in total, two hours apart.
|
The state anxiety scale determines how the individual feels at a certain moment and under certain conditions.
The scale consists of 20 questions and is asked to choose one of the options 'not at all', 'somewhat', 'a lot' and 'completely' depending on the severity of the thoughts or behaviors.
The trait anxiety scale determines how the individual feels, regardless of the situation and conditions, and consists of 20 questions.
In answering this scale, one is asked to choose one of the following options: 'almost never', 'sometimes', 'most of the time' and 'almost always', depending on the frequency of the thoughts or behaviors.
|
It was applied twice in total, two hours apart.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Similarity Scale for Fatigue
Time Frame: It was applied twice in total, two hours apart.
|
The scale has sub-dimensions of fatigue and energy . It consists of a total of 18 items in two sub-dimensions. The scale consists of 10 cm horizontal lines with positive expressions at one end and negative expressions at the other end of each item. While the items of the fatigue sub-dimension progress from positive to negative expressions, the items of the energy sub-dimension are in the opposite order. The lowest score obtained in the fatigue sub-dimension is zero and the highest score is 130. In the energy sub-dimension, scores are calculated between 0 and 50 points. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate that the severity of fatigue increases. |
It was applied twice in total, two hours apart.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nurseli SOYLU ERENER, TC Erciyes University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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