Clinical trial NCT06959940: Alternative Method: Chewing Gum in Labor
Official title: Alternative Method to Reduce Pain, Anxiety, Fatigue, and Thirst: Chewing Gum in Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Labor
gum
pain
anxiety
fatigue
thirst
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Power analysis was used to determine the sample. The power of the test was calculated with the G\*Power 3.1 program. The effect size in the interventional study conducted by Gundogdu (2019) on pregnant women was based on 0.932. In order to exceed the 95% value in determining the power of the study, it was determined that 94 people, including at least 47 people in the groups, should be reached the 5% significance level and 0.95 effect size (df=0.75; t=1.676).
Primary purpose: TREATMENT

Brief summary: This study is a clinical trial. It aimed to examine the effects of chewing gum on pain, anxiety, fatigue, and thirst in pregnant women (47 experiments; 47 controls) in the first stage of labor. Criteria for inclusion in the study: Pregnant women who gave birth vaginally; voluntarily accept to participate in the research. Exclusion criteria from the study: Pregnant women who have auditory or mental health problems; whose baby dies during labor, who with cervical dilatation of 5 cm or more, who receiving epidural anesthesia, do not like chewing gum, have difficulty chewing, such as weak/loose-fitting dentures. The pain, anxiety, fatigue, and thirst levels of the pregnant women in the control group were evaluated with scales every two hours until their dilatation reached 5 cm. Pregnant women in the experimental group chewed gum and their pain, anxiety, fatigue and thirst levels were evaluated with scales every two hours until their dilation reached 5 cm.

The main questions it aims to answer are:

* Chewing gum during labor is not effective in reducing pain, anxiety, fatigue, and thirst levels.
* Chewing gum during labor; It is effective in reducing the level of pain.
* Chewing gum during labor; It is effective in reducing anxiety.
* Chewing gum during labor; It is effective in reducing thirst.
* Chewing gum during labor; It is effective in reducing fatigue. Routine medical treatment of pregnant women continued all groups. Only pregnant women who in the experimental group chewed gum also.

Detailed description: Objective: In this study, it was aimed to examine the effects of chewing gum on pain, anxiety, fatigue and thirst in pregnant women in the first stage of normal labor.

Methods: The study was conducted in a randomized controlled experimental manner. The universe consisted of all pregnant women who applied to the delivery room of a public institution between April and November 2022. Power analysis was used to determine the sample. 94 pregnant women (47 experiments;47 controls) were included in the study. The study was started after the approval of the ethics committee and the institution. As a data collection tool in the research;"Personal Information Form","Gum Chewing Follow-up Form" and "Pregnant Follow-up Form" were used.

Eligibility criteria: Inclusion Criteria:

* Vaginal delivery,
* Who volunteered to participate in the research

Exclusion Criteria:

* Have auditory or mental health problems,
* The baby dies during labour,
* Cervical dilatation of 5 cm or more,
* Receiving epidural anaesthesia,
* People who don't like chewing gum,
* Chewing difficulties due to weak/loose prostheses

Primary outcomes:
measure: 2
timeFrame: Anxiety scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
measure: 1
timeFrame: Pain scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
measure: 3
timeFrame: Fatigue scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
measure: 4
timeFrame: Thirst scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
Study officials:
References: