Episiotomy WoundNCT06552104
The Effects of Acupressure Applied to the Primiparous During Episiotomy
A study testing ACUPRESSURE APPLI ACUPRESSURE APPLICATION in people with Episiotomy Wound and Pain, run by Esra SABANCI BARANSEL at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous. The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Episiotomy Wound, Pain, Anxiety
- What is being tested?
- ACUPRESSURE APPLI ACUPRESSURE APPLICATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 or older,
- having a single healthy newborn,
- Giving spontaneous birth through a medio-lateral episiotomy incision,
- No signs of infection such as vaginal redness or swelling,
- Women with full and healthy tissue integrity in the area where acupressure will be applied.
Who cannot join
- The need to use unusual lidocaine during episiotomy repair (lidocaine 2% higher than 5 ml),
- having any postpartum complications (such as bleeding, hypertension).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Acupressure Applied to the Primiparous During Episiotomy Repair on Pain and Anxiety Levels
This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.
The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.
Read the detailed description
Introduction: This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.
Methods: The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.
- Conditions
- Episiotomy Wound, Pain, Anxiety
- Being tested
- ACUPRESSURE APPLI ACUPRESSURE APPLICATION
- Keywords
- Acupressure, episiotomy, primiparous
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUPRESSURE APPLI ACUPRESSURE APPLICATIONBehavioural
Pre-test data were collected from participants who met the inclusion criteria and volunteered to participate in the study by researcher BI in the LDP rooms during the latency period of labor. Post-test data were obtained by the same researcher 16 hours after the cesarean section. Data were obtained using the Personal Information Form, Episiotomy Evaluation Form (EEF), Visual Analog Scale (VAS), and Spielberger Manual for State-Trait Anxiety Inventory (STAI).
| Study group | Role | What they receive |
|---|---|---|
| ACUPRESSURE | Experimental | In the study, acupressure was applied to the LI4 and HT7 points of the women for approximately 8-11 minutes during the episiotomy repair by BI, one of the researchers who has an acupressure application certificate. The researcher received training and certification in acupressure techniques before starting the intervention.During the episiotomy repair, acupressure was applied by the researcher twice in total. The first acupressure application was started with the first episiotomy suture being placed during the episiotomy repair (with the start of the internal perineal suturing). The second acupressure application was started with the end of the internal perineal suture and the first episiotomy suture of the skin suture. Each application was applied for approximately 4-6 minutes. Receives: Behavioral: ACUPRESSURE APPLI ACUPRESSURE APPLICATION |
| Control group | No intervention | control groups Control group standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
The VAS was used to assess the pain severity of the incision site. The VAS is a scale created in the range of 0-100 mm. According to the scale, a score of 0 mm indicates that the pain is not severe at all, and a score of 100 mm indicates that the pain is extremely severe
Measured: Change inbreastfeeding self-efficacy levels at 6 weeks change in pain after acupressure
Secondary outcomes (1)
STAI
STAI was developed by Spielberger et al. (1970) to measure state and trait anxiety levels, and its adaptation, validity, and reliability study was conducted by Öner and Le Compte (1983) for the Turkish society. The STAI is a 20-item inventory, and a high score indicates that the individual has a high level of anxiety, while a low score indicates that the anxiety level is low. The lowest score that can be obtained from the scale is 20, and the highest score is 80. This scale, which is a 4-point Likert-type scale, is graded as Not at All, A Little, A Lot, and Extremely.
Measured: Change inbreastfeeding self-efficacy levels at 6 weeks change in anxiety after acupressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jun 2023
- Primary completion1 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episiotomy WoundStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esra SABANCI BARANSEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esra SABANCI BARANSEL, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552104
- Sponsor's protocol ID
- 2023/ 4576
- Status last verified
- Sep 2024
- First submitted
- 1 Aug 2024
- Last updated
- 27 Sep 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupressure Applied to the Primiparous During Episiotomy Repair on Pain and Anxiety Levels
- ClinicalTrials.gov ID
- NCT06552104
- Acronym / sponsor ID
- 2023/ 4576
- Conditions
- Episiotomy Wound, Pain, Anxiety
- Keywords
- Acupressure, episiotomy, primiparous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Esra SABANCI BARANSELUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 13 Aug 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.
This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.
The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.
Detailed description
Introduction: This study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous.
Methods: The study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between June and December 2023. Acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. Visual Analog Scale (VAS) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the Spielberger Manual for State-Trait Anxiety Inventory (STAI) was used after the second intervention to determine the anxiety levels of the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACUPRESSURE | Experimental | Behavioral: ACUPRESSURE APPLI ACUPRESSURE APPLICATIONIn the study, acupressure was applied to the LI4 and HT7 points of the women for approximately 8-11 minutes during the episiotomy repair by BI, one of the researchers who has an acupressure application certificate. The researcher received training and certification in acupressure techniques before starting the intervention.During the episiotomy repair, acupressure was applied by the researcher twice in total. The first acupressure application was started with the first episiotomy suture being placed during the episiotomy repair (with the start of the internal perineal suturing). The second acupressure application was started with the end of the internal perineal suture and the first episiotomy suture of the skin suture. Each application was applied for approximately 4-6 minutes. |
| Control group | No intervention | –control groups Control group standard care group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being 18 or older,
- having a single healthy newborn,
- Giving spontaneous birth through a medio-lateral episiotomy incision,
- No signs of infection such as vaginal redness or swelling,
- Women with full and healthy tissue integrity in the area where acupressure will be applied.
Key exclusion criteria (2 listed)
- The need to use unusual lidocaine during episiotomy repair (lidocaine 2% higher than 5 ml),
- having any postpartum complications (such as bleeding, hypertension).
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 |
|---|---|---|
| ACUPRESSURE APPLI ACUPRESSURE APPLICATIONPre-test data were collected from participants who met the inclusion criteria and volunteered to participate in the study by researcher BI in the LDP rooms during the latency period of labor. Post-test data were obtained by the same researcher 16 hours after the cesarean section. Data were obtained using the Personal Information Form, Episiotomy Evaluation Form (EEF), Visual Analog Scale (VAS), and Spielberger Manual for State-Trait Anxiety Inventory (STAI). | Behavioural | ACUPRESSURE |
Primary outcome
VAS
Time frame: Change inbreastfeeding self-efficacy levels at 6 weeks change in pain after acupressure
The VAS was used to assess the pain severity of the incision site. The VAS is a scale created in the range of 0-100 mm. According to the scale, a score of 0 mm indicates that the pain is not severe at all, and a score of 100 mm indicates that the pain is extremely severe
1 secondary outcome
STAI
Time frame: Change inbreastfeeding self-efficacy levels at 6 weeks change in anxiety after acupressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACUPRESSURE APPLI ACUPRESSURE APPLICATION in people with Episiotomy Wound and Pain, run by Esra SABANCI BARANSEL at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: Change inbreastfeeding self-efficacy levels at 6 weeks change in pain after acupressure). 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 27 Sep 2024.