- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04367038
Endorphin at Labor Pain and Acupressure
The Impact of Different Acupressure Procedures Performed on the Hand During Labor on Endorphin Levels and Labor Pain Perception: A Randomised Controlled Trial
This study was performed to determine the impact of different acupressure procedures, performed on women's hands during labor, on endorphin levels and labor pain perception.
The sample consisted of 140 pregnant women. The study was conducted with three experimental groups and one control group, each including 35 pregnant women. Conventional acupressure and warm and cold acupressure procedures were performed on the Large Intestinal 4 energy meridian zone acupressure point of the experimental group. No procedures were performed on the women in the control group. Data were collected using a "Personal Information Form", "Labor Intervention Follow-up Form", "Visual Analog Scale" and "Verbal Category Scale".
The comparison between the experimental and control groups indicated that the conventional acupressure procedure was effective in reducing labor pain and that the warm acupressure procedure increased endorphin levels.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tokat, Turkey
- Health Research and Training Hospital of Tokat Gaziosmanpaşa University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being a primipara
- Having intact membranes
- No skin diseases (such as urticaria...),
- No use of narcotic drugs
- Having a term pregnancy
- Having a single fetus at vertex position
- Planning to have vaginal delivery
- Having contractions and ongoing regular augmentation
- Having recent augmentation starting periods
- Being in the latent phase (0-3 cm dilatation)
- Having no history of high-risk pregnancy
- Not using analgesic drugs to reduce pain during delivery
- Having no systemic and neurologic diseases
- Having no contraction anomaly (hypotonic or hypertonic contractions)
Exclusion Criteria:
Having any of the above criteria.
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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 |
---|---|
Experimental: Warm Acupressure Procedure Group
Latent phase Visual Analog Scale and Verbal Category Scale I given as pretest First venous blood sample taken Active phase The first warm acupressure procedure was performed for ten minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated three more times at one-hour intervals. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second warm acupressure procedure was performed three times at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken |
Acupressure is non-invasive, safe and effective.
|
Experimental: Cold Acupressure Procedure Group
Latent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous blood sample taken Active phase The first cold acupressure procedure was performed for ten minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated three more times at one-hour intervals. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second cold acupressure procedure was performed three times at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken |
Acupressure is non-invasive, safe and effective.
|
Experimental: Conventional Acupressure Group
Latent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous blood sample taken Active phase Conventional acupressure was performed for 30 minutes on the Large Intestinal 4 energy meridian zone acupressure point on the non-dominant hand. This process was repeated twice more at one-hour intervals. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase The second conventional acupressure procedure was performed twice at one-hour intervals A 30-minute break was given Visual Analog Scale III and Verbal Category Scale III were performed Second venous blood sample taken |
Acupressure is non-invasive, safe and effective.
|
No Intervention: Control Group
Latent phase Visual Analog Scale I and Verbal Category Scale I given as pretest First venous sample taken Active phase No procedure other than the routine clinical practices were carried out. Visual Analog Scale II and Verbal Category Scale II were measured at the end of the active phase Transition phase No procedure other than the normal clinical routines was conducted Visual Analog Scale III and Verbal Category Scale III were performed. Second venous blood sample taken |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
labor pain
Time Frame: through study completion, an average of 1month
|
pain scale
|
through study completion, an average of 1month
|
endorphin levels
Time Frame: through study completion, an average of 1month
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physiological parameter
|
through study completion, an average of 1month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hava Özkan, PhD, Atatürk University Faculty of Health Science, Department of Midwifery,
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.09.2018-04/2
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
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