Labor PainNCT06407505
The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair
A study testing Acupressure group in people with Labor Pain and Perineal Pain, run by Uskudar University.
Trial summary
The study was planned to evaluate the effect of LI4 acupressure application on perineal pain and postpartum comfort during episiotomy repair. Our study was designed as a randomized, controlled, single-blind and placebo design experimental study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Perineal Pain, Postpartum Comfort
- What is being tested?
- Acupressure group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 20 Oct 2025
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speaks Turkish,
- 37-42 weeks gestation and in vaginal labor,
- The one with a single fetus and vertex development,
- Fetal weight between 2000-4000 gr,
- To have performed with mediolateral episiotomy,
- Pregnant women admitted to the delivery room,
Who cannot join
- Vacuum applied
- Forceps delivery
- Vaginal tear/ Disurge
- Anal sphincter damage
- Unusual need for lidocaine during episiotomy repair (more than 10ml)
- Intact perineum
- Any postnatal complications in the newborn.
Trial locations and contacts
No sites are listed yet.
About this study
The study was planned to evaluate the effect of LI4 acupressure application on perineal pain and postpartum comfort during episiotomy repair. Our study was designed as a randomized, controlled, single-blind and placebo design experimental study. The study is planned to be conducted in the maternity ward of Istanbul SBU Kanuni Sultan Süleyman Training and Research Hospital between May 1, 2024 and October 20, 2025. The sample of the study will consist of a total of 90 pregnant women who were hospitalized in the maternity ward and agreed to participate in the study. During the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 seconds in succession and a 10-second break will be taken. A different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be pressed. No intervention will be applied to the control group.
Read the detailed description
Background: Pain relief in the intrapartum period is important for maternal-fetal health. Studies in the literature have generally focused on the first stage of labor. When the labor process is considered as a whole, women may also experience pain during episiotomy repair. In recent years, traditional methods have become more preferred due to the side effects of pharmacologic treatments to relieve pain symptoms. Acupressure, one of the traditional methods, is used to relieve pain and various symptoms by applying pressure on acupuncture points with manual techniques. In the literature, LI4 acupressure is applied to relieve pain symptoms caused by various reasons. However, among the studies reviewed, no study was found to investigate the effect of LI4 acupressure application on perineal pain perceived during episiotomy repair and postpartum comfort level.
Objective: The study was planned to evaluate the effect of LI4 acupressure on perineal pain and postpartum comfort during episiotomy repair.
Materials and Methods: Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study. The study will be conducted in the maternity ward of Istanbul SBÜ Kanuni Sultan Süleyman Training and Research Hospital between May 1, 2024 and October 20, 2025. The sample of the study will consist of a total of 90 pregnant women (experimental group= 30, control group= 30, placebo group= 30) who were hospitalized in the maternity ward and agreed to participate in the study. During the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 s in succession, followed by a 10 s break. The procedure will start with the first suturing. Vital signs will be taken just before the first suturing and after the suturing is completed. A different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be compressed. No intervention will be applied to the control group. Data will be obtained using the Pregnancy Identification Form, Visual Comparison Scale, Postpartum Comfort Scale, Labor Monitoring Form and McGill Pain Scale Short Form. The data obtained from the study will be analyzed in SPSS 23 statistical program in computer environment. In the evaluation of the data, mean, standard deviation, minimum and maximum values, frequency and percentage calculations, t-test and chi-square test will be used.
- Conditions
- Labor Pain, Perineal Pain, Postpartum Comfort
- Being tested
- Acupressure group, Placebo group
- Keywords
- Acupressure, LI4 acupoint, Perineal pain, Postpartum comfort
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure groupOther
Also called LI4 acupressure group, experimental
LI4 acupressure applied group.
Placebo groupOther
Group where acupressure was applied to an area 1.5 cm away at the LI4 acupressure point
| Study group | Role | What they receive |
|---|---|---|
| Acupressure group | Experimental | During the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 s in succession, followed by a 10 s break. Receives: Other: Acupressure group |
| Placebo Group | Placebo comparator | A different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be compressed. Receives: Other: Placebo group |
| Control Group | No intervention | Group receiving routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 item perineal pain intensity measure
Self-reported pain intensity before starting the first suturing, at the end of the 5th application, at the end of the 10th application, immediately after suturing was completed, and at 30 min, 60 min and 120 min after suturing was completed. Each item will be obtained using a visual analog scale. Each item is scored 0-10 (0=no pain; 10=unbearable pain).
Measured: 3 hours
Postpartum perineal pain intensity measure
Pain intensity will be determined 120 minutes after completion of stitching using the McGill scale form.There are 3 sections in the form. The first section consists of 15 descriptive words, 11 of which measure the sensory and 4 of which measure the perceptual dimension of pain. The words in the first section were rated on an intensity scale from 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Very). Three pain scores are obtained from this section: sensory pain score, perceptual pain score and total pain score. In the second section, the pain intensity of the person is measured with 5 word groups ranging from "mild pain" to "unbearable pain". In the third section, the current pain intensity of the patient is measured with a visual comparison scale.
Measured: 30 minutes
Secondary outcomes (1)
Postpartum comfort level
Based on the General Comfort Scale developed by Katharine Kolcaba in 1994, Karakaplan and Yıldız developed a postpartum comfort scale consisting of 34 items to determine postpartum comfort. This scale consists of three sub-dimensions: physical, psychospiritual and sociocultural. In order to evaluate the effect of acupressure application, only the physical sub-dimensions will be examined after two hours.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies 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
- Factorial
- Model description
- Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Deniz, Uskudar University
- Investigators
- Derya Deniz, PhD, Principal investigator, TC Uskudar UniversityOzlem Can Gurkan, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407505
- Sponsor's protocol ID
- 01
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solt Kirca A, Guducu N, Ikiz B. The Effect of Virtual Glasses Application on Pain and Anxiety During Episiotomy Repair: Randomized Controlled Trial. Pain Manag Nurs. 2023 Oct;24(5):e123-e130. doi: 10.1016/j.pmn.2023.06.004. Epub 2023 Jul 16.
PubMed 37455184Orhan M, Bulez A. The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled Study. J Pain Res. 2023 Jun 29;16:2227-2239. doi: 10.2147/JPR.S412883. eCollection 2023.
PubMed 37404226
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair
- ClinicalTrials.gov ID
- NCT06407505
- Acronym / sponsor ID
- 01
- Conditions
- Labor Pain, Perineal Pain, Postpartum Comfort
- Keywords
- Acupressure, LI4 acupoint, Perineal pain, Postpartum comfort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 9 May 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.
The study was planned to evaluate the effect of LI4 acupressure application on perineal pain and postpartum comfort during episiotomy repair. Our study was designed as a randomized, controlled, single-blind and placebo design experimental study. The study is planned to be conducted in the maternity ward of Istanbul SBU Kanuni Sultan Süleyman Training and Research Hospital between May 1, 2024 and October 20, 2025. The sample of the study will consist of a total of 90 pregnant women who were hospitalized in the maternity ward and agreed to participate in the study. During the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 seconds in succession and a 10-second break will be taken. A different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be pressed. No intervention will be applied to the control group.
Detailed description
Background: Pain relief in the intrapartum period is important for maternal-fetal health. Studies in the literature have generally focused on the first stage of labor. When the labor process is considered as a whole, women may also experience pain during episiotomy repair. In recent years, traditional methods have become more preferred due to the side effects of pharmacologic treatments to relieve pain symptoms. Acupressure, one of the traditional methods, is used to relieve pain and various symptoms by applying pressure on acupuncture points with manual techniques. In the literature, LI4 acupressure is applied to relieve pain symptoms caused by various reasons. However, among the studies reviewed, no study was found to investigate the effect of LI4 acupressure application on perineal pain perceived during episiotomy repair and postpartum comfort level.
Objective: The study was planned to evaluate the effect of LI4 acupressure on perineal pain and postpartum comfort during episiotomy repair.
Materials and Methods: Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study. The study will be conducted in the maternity ward of Istanbul SBÜ Kanuni Sultan Süleyman Training and Research Hospital between May 1, 2024 and October 20, 2025. The sample of the study will consist of a total of 90 pregnant women (experimental group= 30, control group= 30, placebo group= 30) who were hospitalized in the maternity ward and agreed to participate in the study. During the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 s in succession, followed by a 10 s break. The procedure will start with the first suturing. Vital signs will be taken just before the first suturing and after the suturing is completed. A different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be compressed. No intervention will be applied to the control group. Data will be obtained using the Pregnancy Identification Form, Visual Comparison Scale, Postpartum Comfort Scale, Labor Monitoring Form and McGill Pain Scale Short Form. The data obtained from the study will be analyzed in SPSS 23 statistical program in computer environment. In the evaluation of the data, mean, standard deviation, minimum and maximum values, frequency and percentage calculations, t-test and chi-square test will be used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Our study was designed as a randomized, controlled, single-blind, placebo-designed experimental study.
| Arm | Type | Receives |
|---|---|---|
| Acupressure group | Experimental | Other: Acupressure groupDuring the episiotomy repair, the LI4 acupuncture point on the right hand of the participants in the experimental group will be compressed 10 times for 30 s in succession, followed by a 10 s break. |
| Placebo Group | Placebo comparator | Other: Placebo groupA different point 1-1.5 cm away from the LI4 acupuncture point on the right hand of the participants in the placebo group will be compressed. |
| Control Group | No intervention | –Group receiving routine care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Speaks Turkish,
- 37-42 weeks gestation and in vaginal labor,
- The one with a single fetus and vertex development,
- Fetal weight between 2000-4000 gr,
- To have performed with mediolateral episiotomy,
Key exclusion criteria (7 listed)
- Vacuum applied
- Forceps delivery
- Vaginal tear/ Disurge
- Anal sphincter damage
- Unusual need for lidocaine during episiotomy repair (more than 10ml)
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 groupAlso: LI4 acupressure group, experimentalLI4 acupressure applied group. | Other | Acupressure group |
| Placebo groupGroup where acupressure was applied to an area 1.5 cm away at the LI4 acupressure point | Other | Placebo Group |
Primary outcome
7 item perineal pain intensity measure
Time frame: 3 hours
Self-reported pain intensity before starting the first suturing, at the end of the 5th application, at the end of the 10th application, immediately after suturing was completed, and at 30 min, 60 min and 120 min after suturing was completed. Each item will be obtained using a visual analog scale. Each item is scored 0-10 (0=no pain; 10=unbearable pain).
Postpartum perineal pain intensity measure
Time frame: 30 minutes
Pain intensity will be determined 120 minutes after completion of stitching using the McGill scale form.There are 3 sections in the form. The first section consists of 15 descriptive words, 11 of which measure the sensory and 4 of which measure the perceptual dimension of pain. The words in the first section were rated on an intensity scale from 0 to 3 (0=None, 1=Mild, 2=Moderate, 3=Very). Three pain scores are obtained from this section: sensory pain score, perceptual pain score and total pain score. In the second section, the pain intensity of the person is measured with 5 word groups ranging from "mild pain" to "unbearable pain". In the third section, the current pain intensity of the patient is measured with a visual comparison scale.
1 secondary outcome
Postpartum comfort level
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Results publication: PubMed 37455184Solt Kirca A, Guducu N, Ikiz B. The Effect of Virtual Glasses Application on Pain and Anxiety During Episiotomy Repair: Randomized Controlled Trial. Pain Manag Nurs. 2023 Oct;24(5):e123-e130. doi: 10.1016/j.pmn.2023.06.004. Epub 2023 Jul 16.
- Results publication: PubMed 37404226Orhan M, Bulez A. The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled Study. J Pain Res. 2023 Jun 29;16:2227-2239. doi: 10.2147/JPR.S412883. eCollection 2023.
- The Effect of Virtual Glasses Application on Pain and Anxiety During Episiotomy Repair: Randomized Controlled TrialLink provided by the sponsor.
- The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled StudyLink provided by the sponsor.
- 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.
Derya Deniz, PhD principal investigator
TC Uskudar University
Ozlem Can Gurkan study director
Marmara University
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure group in people with Labor Pain and Perineal Pain, run by Uskudar University.
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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 May 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Derya Deniz, PhD (+90537312147, derya.deniz@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7 item perineal pain intensity measure (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407505, which also lists 2 linked publications.
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 9 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.