protocolSection identificationModule nctId: NCT06304311, orgStudyIdInfo id: MAHSA/PHD/SON/2024/01, briefTitle: Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-02, primaryCompletionDateStruct date: 2023-10-02, completionDateStruct date: 2024-01-04, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: University of Lahore, class: OTHER, collaborators name: Mahsa University, descriptionModule briefSummary: 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., conditionsModule conditions: Labor Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Routine Obstetrics care & Lamaze breathing techniques and backside massage, outcomesModule primaryOutcomes measure: Labour pain intensity, primaryOutcomes measure: Anxiety level, primaryOutcomes measure: Duration of Labour, primaryOutcomes measure: Maternal self-efficacy, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lady Wallingdon Hospital, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False