NCT04543487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
Last Updated

February 20, 2026

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

August 25, 2020

Last Update Submit

February 18, 2026

Conditions

Keywords

therapeutic touchlabour painanxietychildbirth attitude

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    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

  • State Anxiety Inventory

    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

  • Childbirth Attitudes Questionnaire

    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 Outcomes (3)

  • Visual Analogue Scale

    In the final stage of labor

  • State Anxiety Inventory

    In the final stage of labor

  • Childbirth Attitudes Questionnaire

    In the final stage of labor

Study Arms (1)

Control Group

EXPERIMENTAL

Group name

Other: Therapeutic touch

Interventions

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.

Control Group

Eligibility Criteria

Age19 Years - 41 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Multiparity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sukran Ertekin Pinar

Sivas, Turkey, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty of Health Sciences

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 10, 2020

Study Start

July 1, 2019

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 20, 2026

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations