Labor PainNCT06304311
Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida
A study testing Routine Obstetrics care & Lamaze breathing techniques and backside massage and Routine obstetrics care in people with Labor Pain, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Routine Obstetrics care & Lamaze breathing techniques and backside massage and Routine obstetrics care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2022to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primigravidae
- Age 20-35 years old
- Gestational age of 37-41 weeks
- First stage of labour
- Singleton pregnancy
- Cephalic presentation
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida in Tertiary Care Hospitals, Lahore Pakistan: A Randomized Control Trial
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
- Being tested
- Routine Obstetrics care & Lamaze breathing techniques and backside massage, Routine obstetrics care
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Obstetrics care & Lamaze breathing techniques and backside massageProcedure or surgery
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 careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Obstetrics care (Control) | Active comparator | 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. Receives: Procedure: Routine obstetrics care |
| Routine Obstetrics care & Lamaze breathing techniques and backside massage (Interventional group) | Experimental | 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. Receives: Procedure: Routine Obstetrics care & Lamaze breathing techniques and backside massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labour pain intensity
Labour pain intensity is a measure used to assess the severity or level of pain experienced by a woman during childbirth. It typically involves asking the woman to rate her pain on a scale, often ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. This outcome measure helps healthcare providers understand the woman's level of discomfort during Labour and can guide decisions regarding pain management strategies and interventions to ensure her comfort and well-being throughout the birthing process.
Measured: During 1st stage to 01 day after labour
Anxiety level
Anxiety levels were measured by GAD-7 scoring system. GAD-7 is a brief self-report questionnaire designed to screen for generalized anxiety disorder and assess its severity. It consists of 7 items, and participants rate how often they have been bothered by each symptom over the past two weeks on a scale from 0 to 3. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: During 1st stage to 01 day after labour
Duration of Labour
Duration of labour is a measure used to assess the length of time it takes for a woman to progress through the stages of childbirth, from the onset of regular contractions to the delivery of the baby and placenta. It is typically recorded in hours or minutes and includes the duration of both the active and passive phases of labour, as well as the length of time spent pushing during the second stage. Monitoring the duration of labour is essential for healthcare providers to evaluate the progress of labour, identify potential complications, and make informed decisions regarding interventions or assistance to ensure a safe and healthy delivery for both the mother and baby.
Measured: During 1st stage to 01 day after labour
Maternal self-efficacy
Childbirth Self-Efficacy Inventory (CBSEI) for the measurement of maternal confidence \& self-efficacy By Nancy. K. Lowe, for the experimental and control group. (Tool indicates 1 which indicates not all helpful and 10 very helpful)
Measured: During 1st stage to 01 day after labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 Oct 2022
- Primary completion2 Oct 2023
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Collaborators
- Mahsa University
- Responsible party
- Principal investigator, Muhammad Mansoor Hafeez, University of Lahore
- Investigators
- Prof. Dr. Lim Gek Mul, Study chair, Masha UniversityProf. Dr. Rusli Bin Nordin, Study director, Masha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304311
- Sponsor's protocol ID
- MAHSA/PHD/SON/2024/01
- Status last verified
- May 2026
- First submitted
- 11 Feb 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Till the publication of data nothing will be share
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Backside Massage and Lamaze Breathing on Labour Outcome Among Primigravida in Tertiary Care Hospitals, Lahore Pakistan: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06304311
- Acronym / sponsor ID
- MAHSA/PHD/SON/2024/01
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Collaborators
- Mahsa University
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Obstetrics care (Control) | Active comparator | Procedure: Routine obstetrics careParticipants 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. |
| Routine Obstetrics care & Lamaze breathing techniques and backside massage (Interventional group) | Experimental | Procedure: Routine Obstetrics care & Lamaze breathing techniques and backside massageParticipants 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Primigravidae
- Age 20-35 years old
- Gestational age of 37-41 weeks
- First stage of labour
- Singleton pregnancy
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Obstetrics care & Lamaze breathing techniques and backside massageLamaze 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 or surgery | Routine Obstetrics care & Lamaze breathing techniques and backside massage (Interventional group) |
| Routine obstetrics careParticipants 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. | Procedure or surgery | Routine Obstetrics care (Control) |
Primary outcome
Labour pain intensity
Time frame: During 1st stage to 01 day after labour
Labour pain intensity is a measure used to assess the severity or level of pain experienced by a woman during childbirth. It typically involves asking the woman to rate her pain on a scale, often ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. This outcome measure helps healthcare providers understand the woman's level of discomfort during Labour and can guide decisions regarding pain management strategies and interventions to ensure her comfort and well-being throughout the birthing process.
Anxiety level
Time frame: During 1st stage to 01 day after labour
Anxiety levels were measured by GAD-7 scoring system. GAD-7 is a brief self-report questionnaire designed to screen for generalized anxiety disorder and assess its severity. It consists of 7 items, and participants rate how often they have been bothered by each symptom over the past two weeks on a scale from 0 to 3. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Duration of Labour
Time frame: During 1st stage to 01 day after labour
Duration of labour is a measure used to assess the length of time it takes for a woman to progress through the stages of childbirth, from the onset of regular contractions to the delivery of the baby and placenta. It is typically recorded in hours or minutes and includes the duration of both the active and passive phases of labour, as well as the length of time spent pushing during the second stage. Monitoring the duration of labour is essential for healthcare providers to evaluate the progress of labour, identify potential complications, and make informed decisions regarding interventions or assistance to ensure a safe and healthy delivery for both the mother and baby.
Maternal self-efficacy
Time frame: During 1st stage to 01 day after labour
Childbirth Self-Efficacy Inventory (CBSEI) for the measurement of maternal confidence \& self-efficacy By Nancy. K. Lowe, for the experimental and control group. (Tool indicates 1 which indicates not all helpful and 10 very helpful)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Till the publication of data nothing will be share
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Lim Gek Mul study chair
Masha University
Prof. Dr. Rusli Bin Nordin study director
Masha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Obstetrics care & Lamaze breathing techniques and backside massage and Routine obstetrics care in people with Labor Pain, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labour pain intensity (time frame: During 1st stage to 01 day after labour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.