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Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude (touch)

Primary Purpose

First Pregnancy, Vaginal Delivery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic touch
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for First Pregnancy focused on measuring therapeutic touch, labour pain, anxiety, childbirth attitude

Eligibility Criteria

19 Years - 41 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sukran Ertekin Pinar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Control Group

Arm Description

Group name

Outcomes

Primary Outcome Measures

Scale
Visual Analogue Scale
Inventory
State Anxiety Inventory
Questionnaire
Childbirth Attitudes Questionnaire

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
September 2, 2020
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT04543487
Brief Title
Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
Acronym
touch
Official Title
The Effect of Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Pregnancy, Vaginal Delivery
Keywords
therapeutic touch, labour pain, anxiety, childbirth attitude

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
Group name
Intervention Type
Other
Intervention Name(s)
Therapeutic touch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scale
Description
Visual Analogue Scale
Time Frame
6 months
Title
Inventory
Description
State Anxiety Inventory
Time Frame
6 months
Title
Questionnaire
Description
Childbirth Attitudes Questionnaire
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sukran Ertekin Pinar
City
Sivas
ZIP/Postal Code
58140
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude

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