The Effect of External Pressure Applı̇ed to the Palm on Labor Paı̇n and Childbirth Experı̇ence

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Completed
CT.gov ID
NCT06106867
Collaborator
(none)
60
1
2
8
7.5

Study Details

Study Description

Brief Summary

The study was carried out to evaluate the effect of external pressure applied to the palm on labor pain and childbirth experience.The sample of the randomized controlled study consisted of 60 nulliparous (30 in the experimental group and 30 in the control group) pregnant women who presented to Zeynep Kamil Gynecology and Pediatrics Training and Research Hospital between April and June 2020 to give birth and met the research conditions. The Descriptive Information Form, Follow-Up Form Related to Labor Action, Childbirth Experience Questionnaire (CEQ), and Visual Analogue Scale (VAS) were used in data collection. During the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages of the labor process, palm external pressure was applied to the pregnant women in the experimental group, while standard midwifery care was provided to the pregnant women in the control group. The VAS was applied to both groups at admission to the hospital, before and after the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages, and also at the 30th minute postpartum. Data were analyzed Statistical Package for Social Sciences 24.0 program using number, percentage, mean, standard deviation, the Kolmogorov-Smirnov test, Levene's test and independent samples t-test, one-way ANOVA test, analysis of variance, and chi-square test. In all analyses, p<0.05 values will be considered statistically significant.

Condition or Disease Intervention/Treatment Phase
  • Procedure: External pressure to the palm
N/A

Detailed Description

Labor pain adversely affects pregnant women's perception of the labor process and childbirth. When not taken under control, it causes pregnant women to have negative experiences about the labor process and consequently leads to a decrease in their satisfaction with childbirth. For this reason the study was carried out to evaluate the effect of external pressure applied to the palm on labor pain and childbirth experience. Hypotheses of the research; H 1 : External pressure applied to the palm during labor reduces the level of labor pain. H 1 : External pressure applied to the palm during labor increases the positive birth experience.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of External Pressure Applı̇ed to the Palm on Labor Paı̇n and Childbirth Experı̇ence
Actual Study Start Date :
Apr 30, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Information about applying external pressure to the palm was provided to the pregnant women in the experimental group. The researcher practically explained how, when and for how long to apply external pressure to the palm. The researcher introduced the comb to be used in the application of external pressure to the palm, and the application stage of the study was started.

Procedure: External pressure to the palm
During the 5-6 cm, 7-8 cm, and 9-10 cm cervical dilatation stages of the labor process, palm external pressure was applied to the pregnant women in the experimental group.

No Intervention: Control Group

Routine midwifery care and services applied to all pregnant women in the hospital were provided to the participants in the control group.

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) Level of labor pain will be measured with VAS. [30 minutes]

    (min:0, max:10)

  2. The Childbirth Experience Questionnaire (CEQ) [At the 30th minute postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being aged between 18-35 years

  • Being a nulliparous pregnant woman

  • Being pregnant at term (between the 37th and 42nd weeks of gestation)

  • Expecting the vaginal delivery

  • Being in singleton and vertex presentation

  • The weight of the fetus between 2500-4000 g

  • Having had an uncomplicated pregnancy process for the pregnant woman and the fetus

  • Being in the latent phase (cervical dilatation below 4 cm)

Exclusion Criteria:
  • Having high-risk pregnancy

  • Having any disease and disability related to the hand and palm

  • Having any health problem preventing communication

  • Being a pregnant woman in need of analgesics

  • Pregnant women to whom non-pharmacological methods were applied to relieve pain

  • Undergoing cesarean section due to possible indication

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University-Cerrahpasa Istanbul Turkey 34500

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Emine Nur Çalımlı Celep, Researcher Assistant

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Emine Nur Çalımlı Celep, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT06106867
Other Study ID Numbers:
  • IUC-ENC
First Posted:
Oct 30, 2023
Last Update Posted:
Oct 30, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Emine Nur Çalımlı Celep, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2023