- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06426329
The Effect of Therapeutic Touch at Birth on Pain, Birth Duration, Traumatic Birth Perception and Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Turkey
-
Sivas, Turkey, Turkey (Türkiye), 58140
- Sukran Ertekin Pinar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
having vacuum, forceps etc. intervention such as
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of care Group
The control group did not receive any treatment.
|
|
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Experimental: Therapeutic touch Group
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Baseline
|
It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.
|
Baseline
|
|
State Anxiety Inventory
Time Frame: Baseline
|
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
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: Postpartum in 2 hour
|
It is a measurement tool used to evaluate pain intensity, where 0 = no pain and 10 = the most severe pain.
|
Postpartum in 2 hour
|
|
State Anxiety Inventory
Time Frame: Postpartum in 2 hour
|
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".
|
Postpartum in 2 hour
|
|
Traumatic Birth Perception Scale
Time Frame: Postpartum in 2 hour
|
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
|
Postpartum in 2 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sukran Ertekin Pinar, Ph.D., Cumhuriyet University
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
- Pain
- Neurologic Manifestations
- Mental Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Anxiety Disorders
- Labor Pain
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Control Groups
- Therapeutic Touch
Other Study ID Numbers
- TR SİVAS 04
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
product manufactured in and exported from the U.S.
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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