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Endorphin at Labor Pain and Acupressure

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Warm Acupressure, Cold Acupressure , Conventional Acupressure
Sponsored by
Serap ÖZTÜRK ALTINAYAK
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring acupressure, labor pain, Midwifery, pregnant women, endorphins, warm acupressure, cold acupressure

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

-

Sites / Locations

  • Health Research and Training Hospital of Tokat Gaziosmanpaşa University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Warm Acupressure Procedure Group

Cold Acupressure Procedure Group

Conventional Acupressure Group

Control Group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

labor pain
pain scale
endorphin levels
physiological parameter

Secondary Outcome Measures

Full Information

First Posted
April 23, 2020
Last Updated
April 28, 2020
Sponsor
Serap ÖZTÜRK ALTINAYAK
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1. Study Identification

Unique Protocol Identification Number
NCT04367038
Brief Title
Endorphin at Labor Pain and Acupressure
Official Title
The Impact of Different Acupressure Procedures Performed on the Hand During Labor on Endorphin Levels and Labor Pain Perception: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Serap ÖZTÜRK ALTINAYAK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
acupressure, labor pain, Midwifery, pregnant women, endorphins, warm acupressure, cold acupressure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Warm Acupressure Procedure Group
Arm Type
Experimental
Arm Description
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
Arm Title
Cold Acupressure Procedure Group
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional Acupressure Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Warm Acupressure, Cold Acupressure , Conventional Acupressure
Intervention Description
Acupressure is non-invasive, safe and effective.
Primary Outcome Measure Information:
Title
labor pain
Description
pain scale
Time Frame
through study completion, an average of 1month
Title
endorphin levels
Description
physiological parameter
Time Frame
through study completion, an average of 1month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hava Özkan, PhD
Organizational Affiliation
Atatürk University Faculty of Health Science, Department of Midwifery,
Official's Role
Study Director
Facility Information:
Facility Name
Health Research and Training Hospital of Tokat Gaziosmanpaşa University
City
Tokat
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I want it published in a journal first.

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Endorphin at Labor Pain and Acupressure

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