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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05380258
Other study ID # KAEK-143-132
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 5, 2021
Est. completion date June 5, 2022

Study information

Verified date March 2023
Source Kastamonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted as a randomized controlled experimental study. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The population of the study consisted of primiparous mothers who applied to the hospital. This study was planned to determine the effects of chewing gum and using a stress ball on the perception of labor pain, duration of labor and birth satisfaction. The study was carried out in two stages. In the first stage, the data were collected in the delivery room, and in the second stage, the postpartum satisfaction levels of the mothers were measured in the postpartum service. The sample number of the investigators' study was determined as 96. Visual analog scale, birth satisfaction scale and birth follow-up form were used for the data of our study.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date June 5, 2022
Est. primary completion date June 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Being primiparous to be in due time - To have spontaneous vaginal delivery - Ability to communicate verbally be between the ages of 18-35 - Not having a risky pregnancy - Having a single fetus in the vertex position - Having started contractions and continuing regularly - Being in the latent phase of action (0-4 cm dilatation) - Not having used any analgesia or using any pain medication to reduce pain during labor Exclusion Criteria: - Mothers who have a cesarean section decision - Risky Pregnant - Multiple Pregnancies - Multiparous pregnant women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
stress ball
Pregnant women with 4-5 cm cervical dilatation were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes when their contractions came, and when the cervical opening was 6-8 cm, they were asked to tighten the ball for 5 seconds and relax for 2 seconds within 20 minutes.
chewing gum
Pregnant women with 4-5 cm cervical dilatation were asked to squeeze the ball for 5 seconds and loosen it for 2 seconds as soon as their contractions came and within 20 minutes, and when the cervical opening was 6-8 cm, they chewed gum again for 20 minutes.

Locations

Country Name City State
Turkey Sahika Simsek Çetinkaya Merkez Kastamonu

Sponsors (1)

Lead Sponsor Collaborator
Kastamonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary labor pain Visual Analog scale I for labor pain was applied in 0-3 cm , Visual Analog Scale II in 4-5 cm and Visual Analog Scale III was applied in 6-8 cm cervical dilatation. The study continues through study completion, an average of 1 year
Primary Duration of labor A birth follow-up form was used from the beginning of cervical dilatation to delivery.
Primary birth satisfaction satisfaction form used postpartum at the 4th hour
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