NCT06426329

Brief Summary

Aim: This study was planned to determine the effect of therapeutic touch applied at birth on pain, birth duration, traumatic birth perception and anxiety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable pregnancy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

February 20, 2026

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

March 27, 2024

Last Update Submit

February 18, 2026

Conditions

Keywords

Therapeutic TouchLabor PainBirth DurationAnxietyTraumatic Birth Perception

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.

    Baseline

  • State Anxiety Inventory

    It is a scale consisting of 20 items that requires the individual to answer how she feels at a certain moment and under certain conditions, taking into account her feelings about the current situation. A score of 0-19 indicates "no anxiety", 20-39 points indicates "mild", 40-59 points indicates "moderate", and 60-79 points indicates "severe anxiety".

    Baseline

  • Traumatic Birth Perception Scale

    It consists of 13 items and measures the woman's level of perception of traumatic birth. (0-26) points: very low perception of traumatic birth (27- 52) points: low level of perception of traumatic birth (53-78) points: perception of moderately traumatic birth (79-104) points: perception of highly traumatic birth (105-130) points: very high perception of traumatic birth

    Baseline

Secondary Outcomes (3)

  • Visual Analogue Scale

    Postpartum in 2 hour

  • State Anxiety Inventory

    Postpartum in 2 hour

  • Traumatic Birth Perception Scale

    Postpartum in 2 hour

Study Arms (2)

Therapeutic touch Group

EXPERIMENTAL

Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the latent phase of the first stage of labour, and the second was done in the active phase of labour.

Behavioral: Therapeutic Touch

Standard of care Group

NO INTERVENTION

The control group did not receive any treatment.

Interventions

Therapeutic touch, as meaningful touch, is included in complementary medicine in the literature. It provides physical, emotional and spiritual relief, improves physiological health, makes the person feel valuable, gives confidence, peace, calmness and increases self-confidence.

Also known as: Control Group
Therapeutic touch Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 having a chronic physical or psychiatric diagnosis Agreeing to participate in the research Not having communication and perception problems Miad (37W\<) pregnancy Having with induction application

You may not qualify if:

  • having vacuum, forceps etc. intervention such as

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 TouchControl Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sukran Ertekin Pinar, Ph.D.

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doç. Profesör Doktor

Study Record Dates

First Submitted

March 27, 2024

First Posted

May 23, 2024

Study Start

January 1, 2024

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

February 20, 2026

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations