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Completed

NCT Number: NCT06959940

Alternative Method: Chewing Gum in Labor

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.

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Key information

Conditions

Labor Pain Anxiety Disorders Fatigue Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

experimental group (gum group)

Other

After the pregnant woman in the experimental group was admitted to the delivery room, the data collection tools "Personal Information Form" and "Pregnant Follow-up Form" were applied. Pregnant women who agreed to participate in the study were given information about chewing gum. Pain, anxiety, fatigue and thirst scales were administered to the pregnant woman before she started chewing gum. The pregnant woman was allowed to chew gum for 15 minutes. At the end of 15 minutes, the measurements were repeated. Applications were repeated as stated above every two hours until the pregnant woman's dilation reached 5 cm. Routine medical treatment of pregnant women continued.

Primary outcomes

  1. 2

    Time frame: 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.

    Change from anxiety scale scores at control group or experimental group in during labor

  2. 1

    Time frame: 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.

    Change from pain scale scores at control group or experimental group in during labor

  3. 3

    Time frame: 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.

    Change from fatigue scale scores at control group or experimental group in during labor

  4. 4

    Time frame: 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.

    Change from thirst scale scores at control group or experimental group in during labor

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

Alternative Method to Reduce Pain, Anxiety, Fatigue, and Thirst: Chewing Gum in Labor

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 7, 2025
Registry last updated
May 7, 2025

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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