Effects of Music Application and Gum Chewing on Pain, Anxiety, and Patient Satisfaction During Episiotomy Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Lacerations and episiotomies are serious procedures requiring surgical stitches. Therefore, pain occurs during episiotomy repair. Pain during episiotomy repair also causes anxiety, which in turn exacerbates pain. The goal of pain management is to alleviate pain without experiencing side effects. Midwives and nurses responsible for labor management play an active role in the use of nonpharmacological interventions to manage pain and anxiety during episiotomy repair.
No studies in the literature have been found that combine music and chewing gum during episiotomy repair. This study aims to determine the effects of music and chewing gum during episiotomy repair on pain, anxiety, and patient satisfaction.
This study will be to determine the effects of music and chewing gum during episiotomy repair on pain, anxiety, and patient satisfaction.
详细描述
Midwives and nurses responsible for labor management play an active role in the use of nonpharmacological interventions to manage pain and anxiety during episiotomy repair.
This study will be a three-group randomized controlled trial to determine the effects of music and chewing gum during episiotomy repair on pain, anxiety, and patient satisfaction.
Research Location and Time Research data collection will be conducted in the delivery room at Adana City Training and Research Hospital between December 2025 and February 2026.
2.3. Research Population and Sample The research population will consist of women who underwent vaginal delivery and episiotomy repair in the delivery room at Adana Training and Research Hospital who meet the study criteria. The research sample will be calculated using a power analysis following a preliminary study (10 music groups, 10 chewing gum groups, and 10 control groups)
Data Collection Tools Data will be a Pregnancy Information Form, a Labor Monitoring Form, Visual Analog Scale (VAS) Pain Score , the State Anxiety Inventory and the Patient Perception of Nursing Care Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Study participation criteria
- •Women aged 18-49,
- •Primiparous,
- •Having a medio-lateral episiotomy,
- •Having a singleton pregnancy,
- •Vertex presentation,
- •Having given birth vaginally,
- •Having an episiotomy length of 4-5 cm,
- •Having an uncomplicated newborn,
- •Volunteering to participate in the study,
- •Being able to speak and understand Turkish.
排除标准
- •Women who experienced deep lacerations (anal sphincter injuries, 3rd and 4th degree lacerations) during labor,
- •Those who underwent operative delivery (with vacuum or forceps),
- •Those with visual, hearing, or sensory impairments,
- •Those who were not diagnosed with a psychiatric disorder but had problems,
- •Those diagnosed with a high-risk pregnancy,
- •Those who had any signs of infection, such as vaginal redness or swelling,
- •Those who developed complications during any stage of labor,
- •Women with chronic illnesses (diabetes mellitus, thyroid disease, and hypertension) will not be included in the study.
研究组 & 干预措施
Music group
Women in the music group will listen to their preferred music using an Music Headphones connected to speakers in the delivery room between the beginning and end of the episiotomy repair (15-20 minutes).
干预措施: Music (Behavioral)
Gum Chewing group
Women in the music group will listen to their preferred music using an Music Headphones connected to speakers in the delivery room between the beginning and end of the episiotomy repair (15-20 minutes).
Gum group protocol: Women assigned to the gum group will chew plain gum between the beginning and end of the episiotomy repair (15-20 minutes). They will be asked to chew the same brand of easy-to-chew, sugar-free gum that does not contain sorbitol or xylitol. Sugar-free gum is preferred to avoid the risk of GI problems if swallowed with sorbitol-containing gum, and the risk of diarrhea if consumed in excess with xylitol. Given the risk of aspiration while chewing gum, the woman will be positioned in a semi-fowler position.
干预措施: Gum Chewing (Behavioral)
Control group
Pregnant women in the control group will be administered an informed consent form, a pregnant information form, and a labor monitoring form during the active phase of the first stage. Pregnant women in the control group will not deviate from routine procedures performed in the delivery room.
结局指标
主要结局
Visual Analog Scale
时间窗: The research period for a participant takes approximately 1 day
The Visual Analog Scale (VAS) is used to assess pain intensity. The scale can be scored from 0 to 10 To be collected through a survey. The collected data were planned to be analyzed using SPSS with mean and standard deviation.
The State Anxiety Scale
时间窗: The research period for a participant takes approximately 1 day
The State Anxiety Scale (SAAS) was developed by Spielberger et al. The State Anxiety Scale has 20 items. It is used to measure anxiety symptoms. The items describing emotions and behaviors in the scale are scored on a 4-point Likert-type scale: "(1) Not at all," "(2) A little," "(3) A lot," and "(4) Completely." The scale can be scored from 20 to 80. The scale can be scored from 20 to 80 The collected data were planned to be analyzed using SPSS with mean and standard deviation.
The PATIENT'S PERCEPTION SCALE
时间窗: The research period for a participant takes approximately 1 day
The PATIENT'S PERCEPTION SCALE scale was developed by Dopier et al. It was developed to measure patients' perceptions of nursing care and their satisfaction with it. The five-point Likert-type scale includes 15 statements regarding the quality of nursing care. Thus, The scale can be scored from 15 to 75. The scale can be scored from 20 to 80. The collected data were planned to be analyzed using SPSS with mean and standard deviation.
次要结局
未报告次要终点
研究者
Ayşe Sevim AKBAY KISA
Teaching Assistant
Suleyman Demirel University