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

NCT ID: NCT06304311

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-02
• Study Completion Date: 2024-01-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Routine Obstetrics care (Control)

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.

Group Type: ACTIVE_COMPARATOR

Routine Obstetrics care & Lamaze breathing techniques and backside massage

Intervention Type: PROCEDURE

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.

Routine Obstetrics care & Lamaze breathing techniques and backside massage (Interventional group)

Participants in the experimental arm received routine obstetrics care, similar to the control group, along with additional interventions of Lamaze breathing techniques and backside massage. Lamaze breathing techniques were taught to participants during antenatal classes or individual sessions, focusing on deep breathing, relaxation, and pain management strategies during labor. Backside massage was administered by trained personnel using gentle, rhythmic strokes on the lower back to alleviate discomfort and promote relaxation during labor. These interventions were integrated into the labor and delivery process alongside routine obstetrics care.

Group Type: EXPERIMENTAL

Routine Obstetrics care & Lamaze breathing techniques and backside massage

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Primigravidae
• Age 20-35 years old
• Gestational age of 37-41 weeks
• First stage of labour
• Singleton pregnancy
• Cephalic presentation
• Regular contractions
• Cervical dilatation of at least 6 cm
• Minimum of three contractions every 10 minutes
• Contraction intensity of at least moderate
• Contraction duration between 30 seconds and 60 seconds

Exclusion Criteria

• Diagnosis of underlying chronic diseases (e.g., cardiovascular disease, kidney disease, diabetes, asthma, mental health disorders, epilepsy or seizure)
• Pregnancy-related diseases (e.g., gestational diabetes, preeclampsia, cephalo-pelvic disproportion, polyhydramnios or oligohydramnios, deep venous thrombosis)
• Pregnancy complications (e.g., placenta praevia, antepartum haemorrhage, fetal distress, administration of analgesics)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mahsa University

OTHER

Sponsor Role: collaborator

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Mansoor Hafeez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prof. Dr. Lim Gek Mul

Role: STUDY_CHAIR

Masha University

Prof. Dr. Rusli Bin Nordin

Role: STUDY_DIRECTOR

Masha University

Locations

Lady Wallingdon Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MAHSA/PHD/SON/2024/01

Identifier Type: -

Identifier Source: org_study_id