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Completed

NCT Number: NCT06106867

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External pressure to the palm

Procedure

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.

Primary outcomes

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

    Time frame: 30 minutes

    (min:0, max:10)

  2. The Childbirth Experience Questionnaire (CEQ)

    Time frame: At the 30th minute postpartum

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 30, 2023
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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