Effectiveness of Backside Massage & Lamaze Breathing on Labour Outcome

Status Completed

Clinical Trial Summary

The study aims to investigate the effects of a combination of Lamaze breathing exercises and backside massage on the labor experiences of primigravidae in Pakistan. Labour pain, if left unaddressed, can lead to abnormal labor, hence the importance of effective pain management techniques. Lamaze breathing techniques are non-pharmacological methods aimed at psychologically and physically preparing mothers for drug-free childbirth. Backside massage therapy is another non-invasive intervention that can help to reduce pain and anxiety during labor. The study will involve a randomized controlled trial with two groups: an intervention group receiving backside massage and Lamaze breathing along with standard labor care, and a control group receiving only standard labor care. Primigravidae between 26 to 34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal departments. Eligible participants will be randomly allocated to either group to minimize bias. The backside massage therapy intervention will be administered by trained massage therapists. Outcome measures include level of labor pain and anxiety levels, maternal stress hormone levels (adrenocorticotropic hormone, cortisol, and oxytocin), maternal vital signs, fetal heart rate, labor duration, APGAR scores, and maternal satisfaction and self-efficacy. The sample size of 90 participants (45 in each group) has been determined to achieve a 95% power level with a 5% error rate, accounting for a 20% attrition rate. Data analysis will employ mixed-effect regression models, time series analyses, paired t-tests, or equivalent non-parametric tests to assess between-group and within-group outcome measures. The study aims to provide valuable insights into the efficacy of combining Lamaze breathing exercises and backside massage therapy as complementary interventions for managing labor pain and anxiety among primigravidae in Pakistan, potentially reducing the need for medically unnecessary cesarean sections and improving maternal and neonatal outcomes.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Labor Pain

Clinical Trial Details

NCT number	NCT06304311
Study type	Interventional
Source	University of Lahore
Contact
Status	Completed
Phase	N/A
Start date	October 2, 2022
Completion date	January 4, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03539562` - Therapeutic Rest to Delay Admission in Early Labor: A Prospective Study on Morphine Sleep
Not yet recruiting	`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
Recruiting	`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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms