Clinical trial NCT06740734: The Effect of Stress Ball and Expressive Touch Application
Official title: The Effect of Stress Ball and Expressive Touch Application on Pain, Mobilization and Breastfeeding During Episiotomy Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Birth Trauma
Keywords: Pain Management
Midwifery
Episiotomy
Stress Ball
Expressive Touch
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention The pregnant women who were randomly included in the study and control groups by going to the clinic during the study period by the researcher will first fill out the "Informed Volunteer Consent Form" and "Pregnant Identifier Form (Pregnant Identifier Information-Labor and Episiotomy Follow-up Form first 8 questions)".

Implementation process

* Group 1; Stress ball
* Group 2 Expressive touch after cesarean
* Control Group will be given routine care.

Study Group 1: Sterile Stress ball during mediolateral episiotomy repair for pregnant women who received stress ball application. Participants in the stress ball group will be asked to squeeze and loosen the stress ball in their hand (Ozen et al., 2023).

Group 3 -Those who received expressive touch During mediolateral episiotomy repair, expressive touch will be applied to one of the mother's hands by the researcher for an average of 15-20 minutes (Association, 2023.).

In the Control Group The women in the control group receiv
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

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Exclusion Criteria:

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

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Primary outcomes:
measure: Visual Analog Scale
timeFrame: 1 HOUR
measure: Mobilization
timeFrame: 1 HOUR
measure: 6-Minute Walk Test (6MWT)
timeFrame: 1 HOUR
measure: Bristol Breastfeeding Assessment Scale;
timeFrame: 1 HOUR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: