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

NCT06304311 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Labor Pain

Interventions

PROCEDURE

Routine Obstetrics care & Lamaze breathing techniques and backside massage

Lamaze breathing techniques Five breathing patterns were introduced namely- cleansing breathing for relaxation, slow-paced breathing, modified-paced breathing and patterned- paced breathing. These patterns were used during and following contractions. Gentle pushing, and breath-hold during pushing were instructed during the second stage of labor which encouraged descent of the baby. Backside massage during 2nd stage of labor by the trained massage therapist.

PROCEDURE

Routine obstetrics care

Participants in the control arm received routine obstetrics care, which typically includes standard prenatal care, monitoring during labor, and delivery management according to established hospital protocols. There were no additional interventions or techniques implemented beyond standard practice for managing labor and delivery.

Sponsors & Collaborators

  • Mahsa University

    collaborator OTHER
  • University of Lahore

    lead OTHER

Principal Investigators

  • Prof. Dr. Lim Gek Mul · Masha University

  • Prof. Dr. Rusli Bin Nordin · Masha University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-02
Primary Completion
2023-10-02
Completion
2024-01-04

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06304311 on ClinicalTrials.gov