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临床试验/NCT06740734
NCT06740734尚未招募不适用

The Effect of Stress Ball and Expressive Touch Application on Pain, Mobilization and Breastfeeding During Episiotomy Repair

Mine Gokduman Keles0 个研究点目标入组 105 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
105
主要终点
Visual Analog Scale

研究概览

简要总结

Purpose: The study will be conducted to examine the effects of stress ball and expressive touch application on pain, mobilization and breastfeeding during episiotomy repair. Materials and Methods: In the randomized controlled experimental study, data will be obtained using the "VAS pain score", "6 Minute Walk Test" Bristol Breastfeeding Assessment Scale. Stress Ball and Expressive Touch will be applied to the women in the study group during the episiotomy application and no application will be applied to the patients in the control group during the procedure.

详细描述

Introduction Episiotomy is a controlled surgical incision made in the perineum to widen the vaginal opening in the second stage of labor . Although limited and indicated use of episiotomy is recommended, it is applied in around 40%.

Episiotomy procedure is observed to affect sexual health in the short term; pain, anxiety, limited mobility, difficulties in micturition and defecation . In the long term, it is seen that the fear of episiotomy in pregnant women increases the rate of elective cesarean section . The use of sleep-inducing drugs to reduce pain during episiotomy repair can cause side effects such as changes in fetal heart rate and decrease in maternal blood pressure . Evidence-based practices recommend the use of various nonpharmacological methods to reduce pain during episiotomy repair . Evidence-based practices support stress ball and expressive touch in pain management .

Stress ball; is a nonpharmacological method that reduces the feeling of pain by pulling pain-related receptors in the brain to another point.In the literature, stress ball is seen to be used to reduce pain during endoscopy , peripheral intravenous catheter application ,, and gynecological procedures .Again, expressive Touch is an approach that aims to regulate, increase, balance and protect energy to heal diseases or symptoms caused by imbalance in vital energy fields .It is a consciously directed energy exchange in which the practitioner uses their hands as a focal point to facilitate the process .It has been reported in the literature that expressive touch reduces women's pain in labor .Women in labor and early postpartum need verbal and nonverbal communication from midwives .

Reducing pain during episiotomy repair is available in the literature .However, there are limited studies on long-term results .. In the current literature, it was aimed to determine the effects of stress ball and expressive touch application on pain, mobilization and breastfeeding during episiotomy repair and to pioneer future research. It is thought that the results obtained in this study will significantly contribute to women's positive birth experiences and the development of midwifery practices.

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 (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Days 至 35 Days(Child)
性别
Female
接受健康志愿者
是

入选标准

  • •Women who speak Turkish, are between the ages of 18-35, primiparous, gestational age between 37-42, who have undergone mediolateral episiotomy,

排除标准

  • •Women diagnosed with risky pregnancies, those with vision and hearing problems, those with deep lacerations during delivery, those with 3rd and 4th degree lacerations.

研究组 & 干预措施

Control Group

No Intervention

The group will be given routine care

Stress ball

Active Comparator

Sterile Stress ball applied to pregnant women during mediolateral episiotomy repair. Participants in the stress ball group will be asked to squeeze and loosen the stress ball in their hands

干预措施: Stress ball (Behavioral)

Expressive touch applications

Active Comparator

During the mediolateral episiotomy repair, expressive touch will be applied to one hand of the mother by the researcher, lasting approximately 15-20 minutes.

干预措施: Expressive touch applications (Behavioral)

结局指标

主要结局

Visual Analog Scale

时间窗: 1 HOUR

VAS pain score is used to evaluate pain severity. Pain on a numerical rating scale ranges from 0 (absence of pain) to 10 (unbearable pain).

Mobilization

时间窗: 1 HOUR

In the first 48 hours after birth, the first postpartum mobilization hour, duration, and the number of subsequent mobilizations will be recorded (Prokopowicz, Korzeniewska, Byrka, \& Obstetrics, 2021). The decision to start or continue mobilization will be made by the healthcare professional working in the clinic. Women's mobilization status will be evaluated. The examiner will note the success or failure of the patient's mobilization along with its duration. (The beginning of the measurement was determined as the moment the patient got out of bed from a sitting position, and the end of the measurement was determined as the moment the patient returned to bed). If the patient got out of bed and started walking (took at least one step), he received a score of 1 (successful) on the questionnaire. If he stood up but did not take a single step while returning to a sitting position, he received a score of 0. Mobilization time was measured in minutes.

6-Minute Walk Test (6MWT)

时间窗: 1 HOUR

6MWT will be used to evaluate the physical functions of the patients. During this test, a 30-meter-long hard-surfaced track will be walked at a normal pace for six minutes. This track is marked every 3 meters and a cone is placed at the end of this 30-meter track and the same track is returned around it. The researcher will record the distance the patient walks in 6 minutes in meters. The test will be performed in a 60-meter long hospital corridor

Bristol Breastfeeding Assessment Scale;

时间窗: 1 HOUR

"Bristol Breastfeeding Assessment Scale (BEDÖ) was developed by Jenny Ingram in 2014 and adapted to Turkish by Dolgun and her friends in 2017 (İnal, Erdim, Korkut, \& Dolgun). The scale was developed to evaluate breastfeeding problems and adequacy frequently encountered in the postpartum period. The mother is observed by a health professional during breastfeeding and the form is filled out by evaluating the mother and the baby in line with the criteria. The application time of the scale is 5-10 minutes. While the Cronbach's Alpha value of the original form of the tool was found to be 0.68, it was found to be 0.77 in the Turkish adaptation study. In our study, the reliability coefficient Chronbach's Alpha value was determined as ..... The measurement tool is a Likert-type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing" (İnal et al.).

次要结局

未报告次要终点

研究者

发起方
Mine Gokduman Keles
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mine Gokduman Keles

Asst.Prof. Mine GÖKDUMAN KELEŞ PhD. Midwifery Department

Burdur Mehmet Akif Ersoy University

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