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

October 27, 2023 updated by: Emine Nur Çalımlı Celep, Istanbul University - Cerrahpasa (IUC)
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34500
        • Istanbul University-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Level of labor pain will be measured with VAS.
Time Frame: 30 minutes
(min:0, max:10)
30 minutes
The Childbirth Experience Questionnaire (CEQ)
Time Frame: At the 30th minute postpartum
At the 30th minute postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emine Nur Çalımlı Celep, Researcher Assistant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IUC-ENC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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