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The effectiveness of breathing exercise, foot reflexology, and back massage (BRM) during the first stage of labor on labor pain, duration, anxiety, satisfaction, stress hormones, and newborn outcomes in women in Saudi Arabia who are pregnant for the first time

Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and new-born outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87414969
Enrollment
145
Registered
2019-05-01
Start date
2019-05-01
Completion date
Unknown
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pregnancy and Childbirth

Interventions

The intervention consists of three components in sequence: breathing exercises, foot reflexology and the back massage on top of standard nursing care in the delivery room. The intervention will last f

Sponsors

Umm al-Qura University
Lead Sponsor
University Putra Malaysia
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Primigravida women without any previous pregnancies such as miscarriages 2. Aged 20 to 35 years 3. At 37 to 41 weeks gestation when in labor 4. Having regular contractions with cervical dilatation of at least 6 cm 5. Regularly attended antenatal clinic from 26 to 34 weeks 6. Singleton pregnancy 7. Cephalic presentation in labor

Exclusion criteria

Exclusion criteria: 1. Diagnosed with chronic diseases before or during the pregnancy, such as cardiovascular diseases, kidney disease, diabetes, asthma, mental health or psychological disorders, epilepsy or seizures 2. Pregnancy-related diseases, such as gestational diabetes, preeclampsia, cephalopelvic disproportion (CPD), polyhydramnios or oligohydramnios, and deep venous thrombosis (DVT) 3. Complicated pregnancy, such as placenta-previa, haemorrhage, fetal distress 4. Use of analgesics other than intramuscular pethidine

Design outcomes

Primary

MeasureTime frame
1. Assessor-rated pain intensity measured using a present behavioral intensity (PBI) scale during a contraction and when there is absence of contraction at baseline, during intervention and post-intervention immediately after the intervention and twice-hourly thereafter during the first stage of labor. During the intervention, the pain intensity will be measured after breathing exercise and foot reflexology therapy (after 25 minutes from the start of the intervention). Similarly, the third pain intensity will be assessed halfway through the massage therapy (after 45 minutes) during and after contraction. The pain measurements for the control group will be taken in a similar manner before and after contraction beginning when the cervix is 6 cm dilated, during the intervention, and two times after intervention in the first stage. 2. Patient-reported pain intensity recorded using a visual analog scale (VAS) during a contraction and when there is absence of contraction at baseline, during intervention and post-intervention immediately after the intervention and twice-hourly thereafter during the first stage of labor. During the intervention, the pain intensity will be measured after breathing exercise and foot reflexology therapy (after 25 minutes from the start of the intervention). Similarly, the third pain intensity will be assessed halfway through the massage therapy (after 45 minutes) during and after contraction. The pain measurements for the control group will be taken in a similar manner before and after contraction beginning when the cervix is 6 cm dilated, during the intervention, and two times after intervention in the first stage. 3. Anxiety during labor assessed using the Anxiety Assessment Scale for Pregnant Women in Labor (AASPWL) . There are nine questions with two sub-dimensions: six questions on the birth process and three questions on motherhood constellation (grouping). The anxiety level will be measured at 6 cm dilati

Secondary

MeasureTime frame
Current secondary outcome measures as of 06/02/2020: 1. Levels of maternal adrenocorticotrophic hormone (ACTH), Cortisol, and Oxytocin in the blood. Samples were taken on before starting the intervention and will be measured again one and a half hour after the pregnant woman has reached 6 cm of cervical dilatation 2. Maternal vital signs measured by usual monitoring pre- and post-intervention 3. Fetal heart rate measured by cardiotocography pre- and post-intervention 4. Duration of labour measured from 3 to 6 cm cervical dilation and from 6 cm to the end of the first stage of labour using a partograph 5. Assessed the new-born health by using Apgar Scores during 1st and 5th min after delivery (taken from the delivery room medical record) 6. Maternal satisfaction assessed using Six Simple Questions (SSQ), a short questionnaire to assess maternal satisfaction during labour and delivery, measured once after delivery of the baby before the transfer of the mother to postnatal wards _____ Previous secondary outcome measures: 1. Duration of labor measured from 3 cm cervical dilation and 6 cm dilation to the end of the first stage of labor using a partograph 2. Maternal satisfaction assessed using Six Simple Questions (SSQ), a short questionnaire to assess maternal satisfaction during labor and delivery, measured once after delivery of the baby before the transfer of the mother to postnatal wards 3. Levels of maternal adrenocorticotrophic hormone (ACTH) and cortisol in the blood. Samples were taken on admission and 90 min after 6 cm dilatation. 4. Levels of maternal oxytocin in the blood. Samples were taken on admission and 90 min after 6 cm dilatation. 5. Maternal vital signs measured by usual monitoring pre- and post-intervention 6. Fetal heart rate me

Countries

Saudi Arabia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026