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Not yet recruitingNCT06740734Updated Dec 18, 2024

The Effect of Stress Ball and Expressive Touch Application

An interventional study of Stress ball and Expressive touch applications in Birth Trauma, sponsored by Mine Gokduman Keles. Not yet recruiting. Open to female participants aged 18 Days to 35 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Mine Gokduman Keles · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Days to 35 Days
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Birth Trauma

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Keywords

  • Pain Management
  • Midwifery
  • Episiotomy
  • Stress Ball
  • Expressive Touch
03

In context

Birth Injuries

33 studies on the registry are indexed under Birth Injuries; 7 are open to participants now.

This study's planned enrollment of 105 is close to the median of 115 across 24 interventional studies indexed under Birth Injuries.

Browse Birth Injuries studies →

Lead sponsor

Mine Gokduman Keles is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Days to 35 Days
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

-

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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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
105 participants (estimated)

Study arms

  • No intervention
    Control Group

    The group will be given routine care

  • Active comparator
    Stress ball

    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

  • Active comparator
    Expressive touch applications

    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

  • BehavioralStress ball

    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.

  • BehavioralExpressive touch applications

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

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 HOUR

  2. 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.

    Time frame: 1 HOUR

  3. 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

    Time frame: 1 HOUR

  4. 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.).

    Time frame: 1 HOUR

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06740734
Lead sponsor
Mine Gokduman Keles
Responsible party
Mine Gokduman Keles (Asst.Prof. Mine GÖKDUMAN KELEŞ PhD. Midwifery Department, Burdur Mehmet Akif Ersoy University) — Sponsor-investigator
First posted
Dec 18, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Mar 30, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Dec 18, 2024

Study contacts

MİNE GÖKDUMAN
Contact
minegokdumankeles@gmail.com
248 213 82 50

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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