Birth TraumaNCT06740734
The Effect of Stress Ball and Expressive Touch Application
A study testing Stress ball and Expressive touch applications in people with Birth Trauma, run by Mine Gokduman Keles.
Trial 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"… Read more about this study
- Who is it for?
- Ages 18 to 35 days, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Trauma
- What is being tested?
- Stress ball and Expressive touch applications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 days
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Women who speak Turkish, are between the ages of 18-35, primiparous, gestational age between 37-42, who have undergone mediolateral episiotomy,
- -
Who cannot join
- Women diagnosed with risky pregnancies, those with vision and hearing problems, those with deep lacerations during delivery, those with 3rd and 4th degree lacerations.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Stress Ball and Expressive Touch Application on Pain, Mobilization and Breastfeeding During Episiotomy Repair
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.
- Conditions
- Birth Trauma
- Being tested
- Stress ball, Expressive touch applications
- Keywords
- Pain Management, Midwifery, Episiotomy, Stress Ball, Expressive Touch
- Medical subject headings
- Birth Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballBehavioural
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.
Expressive touch applicationsBehavioural
During the mediolateral episiotomy repair, expressive touch will be applied to one hand of the mother by the researcher, lasting approximately 15-20 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Expressive touch applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 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.).
Measured: 1 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mine Gokduman Keles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740734
- Sponsor's protocol ID
- Burdur Mehmet Akif Ersoy Unive
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball and Expressive Touch Application on Pain, Mobilization and Breastfeeding During Episiotomy Repair
- ClinicalTrials.gov ID
- NCT06740734
- Acronym / sponsor ID
- Burdur Mehmet Akif Ersoy Unive
- Conditions
- Birth Trauma
- Keywords
- Pain Management, Midwifery, Episiotomy, Stress Ball, Expressive Touch
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mine Gokduman KelesUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The group will be given routine care |
| Stress ball | Active comparator | Behavioral: Stress ballSterile 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 |
| Expressive touch applications | Active comparator | Behavioral: Expressive touch applicationsDuring the mediolateral episiotomy repair, expressive touch will be applied to one hand of the mother by the researcher, lasting approximately 15-20 minutes. |
Who may qualify
- Ages
- 18 to 35 days
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Women who speak Turkish, are between the ages of 18-35, primiparous, gestational age between 37-42, who have undergone mediolateral episiotomy,
- -
Key exclusion criteria (2 listed)
- Women diagnosed with risky pregnancies, those with vision and hearing problems, those with deep lacerations during delivery, those with 3rd and 4th degree lacerations.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress ballSterile 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. | Behavioural | Stress ball |
| Expressive touch applicationsDuring the mediolateral episiotomy repair, expressive touch will be applied to one hand of the mother by the researcher, lasting approximately 15-20 minutes | Behavioural | Expressive touch applications |
Primary outcome
Visual Analog Scale
Time frame: 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
Time frame: 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)
Time frame: 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;
Time frame: 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.).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball and Expressive touch applications in people with Birth Trauma, run by Mine Gokduman Keles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MİNE GÖKDUMAN (248 213 82 50, minegokdumankeles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 1 HOUR). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.