- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04543487
Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude (touch)
The Effect of Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
Introduction: Touching ensures physical, emotional and spiritual relaxation, confidence, peace, calmness and well-being, and increases self-esteem. The aim of this study is to determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude.
Methods: The sample of this randomized controlled experimental research consisted of 80 (intervention group: 40; control group: 40) women. Data were collected using a Personal Information Form, Visual Analogue Scale, State Anxiety Inventory and Childbirth Attitudes Questionnaire.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Turkey
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Sivas, Turkey, Turkey (Türkiye), 58140
- Sukran Ertekin Pinar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a first pregnancy
- Not having a high-risk pregnancy
- Having no health problems with the baby or herself
- Having a single foetus
- Being about to have a vaginal delivery
- Not receiving infertility treatment
- Not having a chronic physical or psychiatric diagnosis
- Agreeing to participate in the research
Exclusion criterion
-Multiparity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
Group name
|
Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices.
The first application was performed in the active phase of the first stage of labour, and the second was done in the second stage of labour.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Inventory
Time Frame: Baseline
|
The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type.
There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in.
High scores indicate high anxiety levels, and low scores indicate low anxiety levels.
|
Baseline
|
|
Visual Analogue Scale
Time Frame: Baseline
|
It is used to assess pain intensity.
The scale is graded from 0 to 10 cm in length, where 0 represents no pain and 10 represents the most severe pain.
It is applied by having the individual mark a point corresponding to the intensity of the pain they feel.
The distance between the marked point and the lowest end of the line is measured in centimeters, and the resulting numerical value indicates the patient's pain intensity.
|
Baseline
|
|
Childbirth Attitudes Questionnaire
Time Frame: Baseline
|
This scale four-point Likert-type questionnaire consists of 16 items and high scores indicate greater anxiety.
Scale scores are calculated by taking the average of the 16 items.
The items on the scale are scored as follows: "1 = No anxiety ", "2 = Low anxiety ", "3 = Moderate anxiety " and "4 = High anxiety ".
Each item on the scale is scored between 1 and 4.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: In the final stage of labor
|
It is used to assess pain intensity.
The scale is graded from 0 to 10 cm in length, where 0 represents no pain and 10 represents the most severe pain.
It is applied by having the individual mark a point corresponding to the intensity of the pain they feel.
The distance between the marked point and the lowest end of the line is measured in centimeters, and the resulting numerical value indicates the patient's pain intensity.
|
In the final stage of labor
|
|
State Anxiety Inventory
Time Frame: In the final stage of labor
|
The inventory consists of four-degree evaluations ranging from "Not at all" to "Completely" in the Likert type.
There are 20 items in the inventory, and the individual is required to define how he/she feels at a certain moment and under certain conditions, and to respond by taking into account his/her feelings about the situation he/she is in.
High scores indicate high anxiety levels, and low scores indicate low anxiety levels.
|
In the final stage of labor
|
|
Childbirth Attitudes Questionnaire
Time Frame: In the final stage of labor
|
This scale four-point Likert-type questionnaire consists of 16 items and high scores indicate greater anxiety.
Scale scores are calculated by taking the average of the 16 items.
The items on the scale are scored as follows: "1 = No anxiety ", "2 = Low anxiety ", "3 = Moderate anxiety " and "4 = High anxiety ".
Each item on the scale is scored between 1 and 4.
|
In the final stage of labor
|
Collaborators and Investigators
Sponsor
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
- TR SIVAS01
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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