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

University of Lahore

Status: Completed

Conditions: Labor Pain

Treatments: Procedure: Routine Obstetrics care & Lamaze breathing techniques and backside massage

Study type: Interventional

Funder types: Other

Identifiers

NCT06304311

MAHSA/PHD/SON/2024/01

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Routine Obstetrics care (Control)

Active Comparator group

Description:

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.

Treatment:

Procedure: Routine Obstetrics care & Lamaze breathing techniques and backside massage

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

Experimental group

Description:

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.

Treatment:

Procedure: Routine Obstetrics care & Lamaze breathing techniques and backside massage