Clinical trial NCT06304311: Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida
Official title: Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida in Tertiary Care Hospitals, Lahore Pakistan: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: University of Lahore
Sponsor class: OTHER
Collaborators: name: Mahsa University
First posted: 2024-03-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Labour pain intensity
timeFrame: During 1st stage to 01 day after labour
measure: Anxiety level
timeFrame: During 1st stage to 01 day after labour
measure: Duration of Labour
timeFrame: During 1st stage to 01 day after labour
measure: Maternal self-efficacy
timeFrame: During 1st stage to 01 day after labour
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lady Wallingdon Hospital
state: Punjab
Study officials:
affiliation: Masha University
name: Prof. Dr. Lim Gek Mul
role: STUDY_CHAIR
affiliation: Masha University
name: Prof. Dr. Rusli Bin Nordin
role: STUDY_DIRECTOR
References: