Labor Pain Clinical Trial
Official title:
The Effect of LI4 Acupressure on Perineal Pain and Postpartum Comfort During Episiotomy Repair
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.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | October 20, 2025 |
Est. primary completion date | October 20, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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, Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Uskudar University |
Orhan 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | 3 hours | |
Primary | 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. | 30 minutes | |
Secondary | Postpartum comfort level | Based on the General Comfort Scale developed by Katharine Kolcaba in 1994, Karakaplan and Yildiz 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. | 30 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03539562 -
Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
|
||
Withdrawn |
NCT04662450 -
Evaluation and Management of Parturients' Pain Intensity
|
N/A | |
Completed |
NCT02885350 -
Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
|
Phase 4 | |
Completed |
NCT02550262 -
Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor
|
N/A | |
Completed |
NCT01598506 -
Intrathecal Hydromorphone for Labor Analgesia
|
Phase 2 | |
Withdrawn |
NCT01636999 -
Comparing Sedara to Butorphanol in Early Labor
|
N/A | |
Completed |
NCT00987441 -
Epidural Labor Analgesia and Infant Neurobehavior
|
N/A | |
Completed |
NCT00755092 -
Effect of Doula in Nulliparas and Multiparas
|
N/A | |
Terminated |
NCT00787176 -
The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
|
N/A | |
Recruiting |
NCT06036797 -
Efficacy and Safety of Hydromorphone-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia
|
Phase 2 | |
Completed |
NCT05512065 -
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women
|
N/A | |
Completed |
NCT05327088 -
Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia
|
Phase 2 | |
Completed |
NCT03103100 -
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation
|
Phase 3 | |
Recruiting |
NCT03623256 -
Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia
|
Phase 4 | |
Active, not recruiting |
NCT02271100 -
Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique
|
N/A | |
Completed |
NCT02926469 -
Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
|
N/A | |
Completed |
NCT03712735 -
Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women
|
Phase 4 | |
Not yet recruiting |
NCT05565274 -
Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients
|
N/A | |
Recruiting |
NCT02575677 -
Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
|
||
Recruiting |
NCT01708668 -
The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia
|
N/A |