The Effect of Stress Ball and Expressive Touch Application

NCT06740734 | Not Yet Recruiting

• 1 other identifier: Burdur Mehmet Akif Ersoy Unive
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Birth Trauma

Keywords

Pain Management; Midwifery; Episiotomy; Stress Ball; Expressive Touch

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale

  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).

  1 HOUR

• Mobilization

  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.

  1 HOUR

• 6-Minute Walk Test (6MWT)

  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

  1 HOUR

• Bristol Breastfeeding Assessment Scale;

  "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.).

  1 HOUR

Study Arms (3)

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

Behavioral: Stress ball

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.

Behavioral: Expressive touch applications

Interventions

Stress ball BEHAVIORAL

Sterile Stress ball for 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.

Stress ball

Expressive touch applications BEHAVIORAL

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

Expressive touch applications

Eligibility Criteria

• Age: 18 Days - 35 Days
• Gender Eligibility Details: primiparous, pregnancy
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mine Gokduman Keles: lead

MeSH Terms

Conditions

Birth Injuries; Agnosia

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

MİNE GÖKDUMAN

CONTACT

248 213 82 50; minegokdumankeles@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst.Prof. Mine GÖKDUMAN KELEŞ PhD. Midwifery Department

Model Details: 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

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2025
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share