BRM Protocol Targets Labour Pain and Anxiety in First-Stage Labour
Labour pain remains one of the most intense pain experiences in obstetrics, particularly for primigravidae entering childbirth for the first time. In Saudi Arabia, a planned randomised controlled trial will test whether a combined package of breathing exercises, foot reflexology and back massage can ease pain and anxiety during the first stage of labour while also influencing maternal stress biology and newborn outcomes. The protocol is built around a simple clinical question with broad bedside implications: can a structured, non-pharmacological intervention alter how labour unfolds for women who have never delivered before?
The study will compare BRM plus standard labour care against standard labour care alone. Participants will be primigravidae between 26 and 34 weeks of gestation who do not have chronic disease or pregnancy-related complications, and recruitment will take place through antenatal clinics. Random allocation will be stratified by intramuscular pethidine use, a design choice that reflects how analgesic exposure can shape both pain reporting and physiological response during labour. By holding that factor in view, the trial aims to separate the effect of the BRM package from the noise introduced by rescue pain relief.
Measuring Pain, Anxiety and the Biology of Stress at 6 cm Dilatation
The protocol places its main assessments at a clinically important point in labour. Baseline measurements will begin at cervical dilatation of 6 cm, then repeat hourly for 2 hours after BRM delivery. Pain and anxiety will be measured during and after uterine contractions, which is a relevant choice because labour discomfort is not static; it rises and falls with contractile activity and psychological anticipation. A single overall pain score would have missed that rhythm. Instead, repeated measures should capture whether the intervention changes both the intensity of contraction-linked pain and the emotional load that often amplifies it.
One sentence captures the trial’s central logic: the intervention is designed to influence both perception and physiology.
Secondary outcomes extend beyond symptom control. Investigators will measure adrenocorticotropic hormone, cortisol and oxytocin, along with maternal vital signs, fetal heart rate, labour duration, Apgar scores and maternal satisfaction. Those markers matter because pain during labour is not only a sensory event; it is tied to sympathetic activation, endocrine stress responses and uterine dynamics. Cortisol and adrenocorticotropic hormone provide a window into the maternal stress axis, while oxytocin is especially relevant in labour because it drives uterine activity and supports coordinated contractions. If BRM can blunt stress-hormone surges, it may theoretically reduce the cascade of anxiety, muscle tension and catecholamine-driven inhibition that can make labour feel longer and more exhausting.
The inclusion of fetal heart rate and Apgar scores broadens the protocol from maternal comfort to perinatal safety. Any intervention used in labour must be judged not just by whether it reduces pain, but by whether it does so without compromising uteroplacental stability or newborn condition after delivery. Labour duration adds another layer of relevance, since prolonged labour can increase fatigue, distress and the likelihood of escalation to pharmacologic or procedural support.
Why the Combined Non-Pharmacological Package Matters
BRM is not a single technique but a bundled intervention. Breathing exercises may help women regulate fear, reduce hyperventilation and maintain a sense of control during contractions. Foot reflexology adds structured tactile stimulation, while back massage can reduce local muscular tension and offer continuous physical reassurance. In practice, the combination may work through several overlapping pathways: distraction, autonomic downregulation, improved coping and a modest attenuation of the stress response. During active labour, those effects can be clinically meaningful even if they do not eliminate pain outright.
A second blunt truth sits beneath the protocol: labour pain is rarely experienced as pain alone.
Anxiety can intensify nociception, and nociception can intensify anxiety. In primigravidae, uncertainty about what is happening in the body often magnifies each contraction. A non-pharmacological approach that includes direct human touch and guided breathing may therefore influence the subjective burden of labour in ways that medication-only strategies do not always address. The trial’s focus on women without major medical or obstetric complications also narrows the question to a relatively low-risk labour population, where comfort measures may be used early and widely if they prove useful.
The intervention will be delivered by a trained massage therapist, which strengthens procedural consistency. Standardization is important in behavioural and tactile interventions because therapist technique, pressure, timing and patient communication can all affect outcomes. Without that consistency, it becomes difficult to know whether results reflect the intervention itself or variability in how it was given.
Sample Size, Analysis Plan and Trial Governance
The planned sample size is 154 women, with 77 in each group after allowing for 20% attrition. That estimate is based on a between-group difference of 0.6 in anxiety scores, with 95% power and a 5% alpha error. The statistical plan includes mixed-effect regression models for between-group and within-group analyses, time series analyses and paired t-tests or equivalent non-parametric tests where appropriate. Those methods fit a repeated-measures labour study, where outcomes evolve over time and are nested within individual participants.
Ethical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in Saudi Arabia on 14 April 2019 and from the Ethics Committee for Research Involving Human Subjects at Universiti Putra Malaysia on 23 October 2019. Written informed consent will be obtained from all participants. Trial registration was completed on 3 May 2019 in the ISRCTN registry.
Because this is a protocol rather than a results paper, no efficacy claim can be made yet. The real test will be whether the BRM package produces measurable changes in labour pain, anxiety, stress hormones and delivery outcomes without introducing safety concerns or practical barriers to implementation. If the intervention works, the implications will extend beyond comfort alone and into a more structured, low-cost approach to labour support in settings where non-drug options are especially valuable. If the outcomes remain neutral, the study will still clarify whether a widely appealing complementary strategy can survive the scrutiny of randomized testing in active labour.