NCT04367038

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 23, 2020

Last Update Submit

April 28, 2020

Conditions

Keywords

acupressurelabor painMidwiferypregnant womenendorphinswarm acupressurecold acupressure

Outcome Measures

Primary Outcomes (2)

  • labor pain

    pain scale

    through study completion, an average of 1month

  • endorphin levels

    physiological parameter

    through study completion, an average of 1month

Study Arms (4)

Warm Acupressure Procedure Group

EXPERIMENTAL

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

Other: Warm Acupressure, Cold Acupressure , Conventional Acupressure

Cold Acupressure Procedure Group

EXPERIMENTAL

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

Other: Warm Acupressure, Cold Acupressure , Conventional Acupressure

Conventional Acupressure Group

EXPERIMENTAL

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

Other: Warm Acupressure, Cold Acupressure , Conventional Acupressure

Control Group

NO INTERVENTION

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

Interventions

Acupressure is non-invasive, safe and effective.

Cold Acupressure Procedure GroupConventional Acupressure GroupWarm Acupressure Procedure Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Having any of the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Research and Training Hospital of Tokat Gaziosmanpaşa University

Tokat Province, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hava Özkan, PhD

    Atatürk University Faculty of Health Science, Department of Midwifery,

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, Academician

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 29, 2020

Study Start

April 25, 2019

Primary Completion

October 31, 2019

Study Completion

January 8, 2020

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

I want it published in a journal first.

Locations