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Effect of Therapeutic Touch on Labor Pain and Hormone Levels

Primary Purpose

Labor Pain, Labor Perception, Hormone Levels and Childbirth Comfort

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Touch
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain, Labor Perception, Hormone Levels and Childbirth Comfort focused on measuring Labor Pain, Therapeutic Touch, The level of hormones, Childbirth

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

being primipara, having a gestational age of 38-42 weeks, planning to have a normal vaginal delivery, having a 3-4 cm dilation in the latent phase, having a single fetus and head presentation, speaking and communicating in Turkish, agreeing to participate in the study, having no high-risk pregnancy.

Exclusion Criteria:

receiving induction, receiving labor analgesia/anesthesia, having sensitivity or problems with touch, having to leave during the intervention due to some reasons such as medical procedures, etc.

Sites / Locations

  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Placebo Group

Arm Description

The experimental group will be administered 15-minute therapeutic touch in the latent phase and after it finishes, the participating pregnant woman will be asked to rest for 30 minutes.

After the mimic (sham) therapeutic touch finishes, the pregnant woman will be asked to rest for 30 minutes.

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS)
VAS is a one-dimensional scale that objectively assesses pregnant woman's perception of pain. VAS is a 100 mm scale (10-cm) that represents lack of pain (0=no pain) on one end and worst possible pain (10=severe pain) on the other end; the scale is used to determine the severity of pain quantitatively. The patient marks any point between the two ends that describe his/her pain severity. The point between lack of pain and the point indicated by the patient is measured using a ruler and recorded as cm. These numeric values indicate the pregnant woman's pain severity.

Secondary Outcome Measures

Maternal Perception of Labor Scale (MPLS)
MPLS is a measurement tool that assesses how mothers perceive their experiences in normal delivery or planned cesarean sections. The sub-scales of the scale include experiences during labor (7 items: 3, 5, 6, 8, 15, 17, 18), experiences during the pain phase of labor (7 items; 1, 2, 4, 7, 9, 10, 16), end of labor (4 items: 22, 23, 24, 25), partner involvement (4 items; 11,12,20,21), and awareness (3 items; 13,14,19). Each item in the MPLS is rated between 1 and 5: 1-Never, 2-A little, 3-Moderate, 4-A lot, and 5-Too much. Since Items 15-16-17-18-19 in the scale include negative statements, these items are scored reversely. Cronbach's alpha value of the scale was 0.90, and the alpha values obtained using two half-test methods were found 0.83 and 0.81.

Full Information

First Posted
December 17, 2021
Last Updated
January 4, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05179915
Brief Title
Effect of Therapeutic Touch on Labor Pain and Hormone Levels
Official Title
Effect of Therapeutic Touch on Labor Pain, Labor Perception, Hormone Levels and Childbirth Comfort
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Levels of pain and anxiety experienced during labor are important factors affecting maternal and infant health. One indicator affecting these factors is labor-specific hormone levels in the uterus. Therapeutic touch practice is a CAT (Complementary and Alternative Therapies) method, and its effect on these factors will be a guide for future practice. The study participants will be women who are accepted to the delivery room of Adana Seyhan Public Hospital affiliated to Adana City Health Administrative of T.R. Ministry of Health between 01th of January 2022 and 01th of January 2023. The sample size of the study was calculated using G*power 3.1.9.6 program. Data obtained from the study conducted by Türkmen and Tuna Orhan (2021) were utilized for the effect size to be used for the calculation of the sample size. With d=0.86 effect size, 5% margin of error (α=0.05), 80% power (1-β=0.80), the sample size was calculated as 23 for the experimental group and 23 for the control group. Considering potential losses in the process, the sample size in both groups was increased by 10% and 25 pregnant women in each group were decided to be included in the study. An average of 15-minute therapeutic touch will be administered in the experimental group. As for the control group, they will be administered fake therapeutic touch for 15 minutes. Data will be collected using the pre and post-therapeutic touch hormone levels, Visual Analogue Scale (VAS), the Childbirth Comfort Scale (CCS), and spit sample. Maternal Perception of Labor Scale (MPLS) data will be collected after the administration is finished. Data will be analyzed using Social Sciences Statistical Package Program 20.0. Very few studies have been conducted on whether labor pain can be decreased effectively using therapeutic touch. However, there are no placebo-controlled and single-blind experimental studies that investigated the effect of therapeutic touch practice during labor on labor pain, labor perception, childbirth comfort, endorphin, oxytocin, and cortisol hormone levels. Therefore, this study will be conducted as a randomized-controlled study to investigate the effect of therapeutic touch on labor pain, labor perception, childbirth comfort, endorphin, oxytocin, and cortisol hormone levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Labor Perception, Hormone Levels and Childbirth Comfort
Keywords
Labor Pain, Therapeutic Touch, The level of hormones, Childbirth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
The experimental group will be administered 15-minute therapeutic touch in the latent phase and after it finishes, the participating pregnant woman will be asked to rest for 30 minutes.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
After the mimic (sham) therapeutic touch finishes, the pregnant woman will be asked to rest for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Therapeutic Touch
Other Intervention Name(s)
Placebo Touch (Mimic Touch)
Intervention Description
In the latent phase of labor, the field energy of the sacral region will be cleared for an average of 15 minutes.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
VAS is a one-dimensional scale that objectively assesses pregnant woman's perception of pain. VAS is a 100 mm scale (10-cm) that represents lack of pain (0=no pain) on one end and worst possible pain (10=severe pain) on the other end; the scale is used to determine the severity of pain quantitatively. The patient marks any point between the two ends that describe his/her pain severity. The point between lack of pain and the point indicated by the patient is measured using a ruler and recorded as cm. These numeric values indicate the pregnant woman's pain severity.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Maternal Perception of Labor Scale (MPLS)
Description
MPLS is a measurement tool that assesses how mothers perceive their experiences in normal delivery or planned cesarean sections. The sub-scales of the scale include experiences during labor (7 items: 3, 5, 6, 8, 15, 17, 18), experiences during the pain phase of labor (7 items; 1, 2, 4, 7, 9, 10, 16), end of labor (4 items: 22, 23, 24, 25), partner involvement (4 items; 11,12,20,21), and awareness (3 items; 13,14,19). Each item in the MPLS is rated between 1 and 5: 1-Never, 2-A little, 3-Moderate, 4-A lot, and 5-Too much. Since Items 15-16-17-18-19 in the scale include negative statements, these items are scored reversely. Cronbach's alpha value of the scale was 0.90, and the alpha values obtained using two half-test methods were found 0.83 and 0.81.
Time Frame
30 minutes
Other Pre-specified Outcome Measures:
Title
The Childbirth Comfort Questionnaire (CCQ)
Description
The original name of the scale was the "Childbirth Comfort Questionnaire", and it was developed by Kerri Durnell Schuiling in 2003 based on Kolcaba's comfort theory (7). Turkish reliability and validity of the Childbirth Comfort Questionnaire were performed by Potur et al. (2015) (8). Cronbach's alpha coefficient of the scale was found 0.75. The 14-item scale is rated on a 5-point scale. Each item is responded considering the comfort in the delivery room. Each item in the original scale is reported to be scored between 1 and 5 (1=I strongly disagree, 2= I disagree, 3=I partly agree, 4= I agree, 5=I strongly agree). Scores to be obtained from the scale range between 14 and 70. Before the total score is calculated, item 2,4,6,9,12,13,14 should be reversed. While higher scores indicate a high level of comfort, lower scores indicate a low level of comfort.
Time Frame
30 minutes
Title
Taking and Preserving the Samples
Description
Spit samples will be taken from pregnant women two times for oxytocin, endorphin, and cortisol analyses, which will include right before starting Therapeutic Touch (TT) in the latent phase of the first phase of labor and 30 minutes after the therapeutic touch. The samples will be collected in 1.5 ml Eppendorf tubes that will have 70 μL spit sample. The samples will be taken to deep freezers at the Genetic Department of Medical Faculty at Çukurova University following the cold-chain rule and waited at -80 °C until the analysis day
Time Frame
30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: being primipara, having a gestational age of 38-42 weeks, planning to have a normal vaginal delivery, having a 3-4 cm dilation in the latent phase, having a single fetus and head presentation, speaking and communicating in Turkish, agreeing to participate in the study, having no high-risk pregnancy. Exclusion Criteria: receiving induction, receiving labor analgesia/anesthesia, having sensitivity or problems with touch, having to leave during the intervention due to some reasons such as medical procedures, etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Gözüyeşil, Phd,Associate Professor
Phone
+905358275061
Ext
3465
Email
ebrugozuyesil@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ebru Gözüyeşil, Phd,Associate Professor
Phone
: +903223386060
Ext
3465
Email
ebrugozuyesil@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Gözüyeşil, PhD. Associate Professor,
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University
City
Adana
State/Province
Sarıcam
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebru Gözüyeşil, PhD. Associate Professor,
Phone
: +905358275061
Email
ebrugozuyesil@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Therapeutic Touch on Labor Pain and Hormone Levels

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