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Clinical Trials/NCT06518772
NCT06518772
Completed
N/A

The Effect of Hot Perfoming on the Soles of the Feet in the First Stage of Labor on Labor

Cumhuriyet University1 site in 1 country60 target enrollmentApril 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Cumhuriyet University
Enrollment
60
Locations
1
Primary Endpoint
Birth Satisfaction Scale Short Form
Status
Completed
Last Updated
last year

Overview

Brief Summary

This research was conducted to determine the effect of applying heat to the soles of the feet during the active phase (5-10 cm dilation) of the first stage of labor. It is a randomized controlled experimental study. In the intervention group, hot gel packs with a temperature of 40-42°C were applied to the soles of the feet for 20 minutes when the cervical dilation was 5 cm. These applications were repeated in the same manner at one-hour intervals until the cervical dilation reached 10 cm. The procedure was terminated when the cervical dilation reached 10 cm. Routine services were applied to the control group. Data were collected using a personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS), and Birth Satisfaction Scale Short Form (BSS-SF)

Detailed Description

This research was conducted to determine the effect of applying heat to the soles of the feet during the active and transition phase (4-10 cm dilation) of the first stage of labor. The research is a randomized controlled experimental study and is conducted in Sivas Cumhuriyet University Practice and Research Hospital Maternity Unit. When the sample size was taken as α = 0.05 and β = 0.10 and 1-β = 0.90 to represent the population in the research, there were 30 individuals in each group and the power of the test was found to be P = 0.90640. The application procedure started with the application of hot gel packets at a temperature of 40-42°C to the soles of the feet of the women in the intervention group for 20 minutes when cervical dilation reaches 5 cm. The first Visual Analog Scale (VAS) evaluation was conducted after the application. Conduction is followed by more evaluations at the 25th (5 minutes after the application), 35th (15 minutes after the application), and 50th minute (30 minutes after the application). These applications were repeated every hour until cervical dilation reached 10 cm. The applicatilon procedure has been stopped after cervical dilation reached 10 cm. The control group received routine service and VAS at the same times. Data were collected with personal information form, Partograph form, APGAR score, Visual Analog Scale (VAS) and Birth Satisfaction Scale Short Form (BSS-R) Wilcoxon test, Mann Whitney U test, Chi-square test, Exact test, Friedman test, t test were used to evaluate the data. The data error level was accepted as 0.05.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
December 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

HATİCE YEŞİLKAYA

Nurse

Cumhuriyet University

Eligibility Criteria

Inclusion Criteria

  • The pregnant woman must be 19 years or older
  • being in the gestational age,
  • Having a singleton pregnancy,
  • The fetus is in a vertex position,
  • Cervical dilatation is 5 cm. to be,
  • Not having a diagnosed chronic physical disease,
  • Not having a diagnosed psychiatric disease,
  • Absence of risky pregnancy and birth,
  • There is no abnormality in the fetus,
  • Being able to speak Turkish and be literate

Exclusion Criteria

  • Not meeting inclusion criteria

Outcomes

Primary Outcomes

Birth Satisfaction Scale Short Form

Time Frame: Application of the birth satisfaction scale 2-4 hours after birth

The scale consists of 10 items and is a Likert type scale. It is scored as "I strongly agree (4 points)", "I agree (3 points)", "I am undecided (2 points)", "I disagree (1 point)", "I strongly disagree (0 points)". 2, 4, 7 of the scale. Items , and 8 are calculated in reverse and the lowest score from the scale is "0" and the highest score is "40". As the score increases, the level of birth satisfaction increases. Scale cut-off scores \<13 are low satisfaction, 14-27 are medium satisfaction, \>28 are high. The scale has three sub-dimensions: quality of care (3,5,6,10), personal characteristics (8.4) and stress experience (1,2,7,9). The total score that can be obtained from the quality of care sub-dimension is 16. The total score that can be obtained from the personal characteristics sub-dimension is 8 and the total score that can be obtained from the stress experience sub-dimension is 16.

Visual Analog Scale

Time Frame: 50 minutes after initial pain assessment

VAS provides rapid measurement of pain intensity in clinical and laboratory conditions. In VAS, the patient is asked to make a mark on a 10 cm horizontal line showing the current situation. In this study, for pain; Markings are made on a 10 cm horizontal line, one end of which indicates the patient's pain is very good (0 = no pain) and the other end is very bad (10 = most severe).

Secondary Outcomes

  • Durations of birth stages with partograph form(during labor)

Study Sites (1)

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