Clinical trial NCT06297031: Heat Application to the Sacral Region and Pain Level During the First Stage of Labor
Official title: The Effect of Heat Application to the Sacral Region During The First Stage of Labor On the Pain Level and the Obstetric Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heat Exposure
Labor Pain
Apgar Score
Duration of Labor
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to determine the effect of hot application applied to the sacral region during first stage of labor on women's pain level and labor process.

Detailed description: It is stated that the pain experienced during labor, which is a physiological process, creates stress and anxiety in women and increases the risk of maternal and neonatal complications. Therefore, keeping labor pain under control is important from an obstetrical perspective. Pain experienced during labor is caused by dilatation of the cervix and uterine contractions, and occurs in different regions at each stage of labor. Due to the descent of the fetal head into the pelvis and the pressure it puts on the lumbosacral plexus, the mother feels pain in her back, waist, legs and hips, especially in the first stage of labor. Although pharmacological and non-pharmacological methods are used in the management of labor pain, they have disadvantages such as experiencing drug-related side effects due to pharmacological methods, causing undesirable effects in the woman and the fetus, the woman not being able to actively participate in the labor and not being able to remember what happened during labor.

Eligibility criteria: Inclusion Criteria:

* Women were over 18 years of age
* Primipara
* Volunteered to participate in the study
* Were in the latent phase of labor (cervical dilatation 1-2 cm)
* Had a single fetus in vertex presentation
* Had no history of pregnancy complications
* Had not undergone any intervention in the sacral region were included in the study

Exclusion Criteria:

* Applied pharmacological pain control methods in the first stage of labor
* Had a cesarean section decision at any stage

Primary outcomes:
measure: Change From Baseline labor Pain at three times
timeFrame: The pain was evaluated three times during labor
Secondary outcomes:
measure: Duration of the first stage of labor
timeFrame: through study completion, an average of 1 day
measure: Change From Baseline APGAR score after delivery
timeFrame: After delivery in two times at first and fifth minutes through study completion, an average of 1 day
measure: Change From Baseline Fetal Heart Rate
timeFrame: A total of three measurement results were obtained (after the cervical dilatation was evaluated as 3-4 cm, 5-6 cm and 7-8 cm)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
affiliation: Istanbul Demiroglu Bilim University
name: Tülay KAVLAK
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goswami S, Jelly P, Sharma SK, Negi R, Sharma R. The effect of heat therapy on pain intensity, duration of labor during first stage among primiparous women and Apgar scores: A systematic review and meta-analysis. Eur J Midwifery. 2022 Nov 28;6:66. doi: 10.18332/ejm/156487. eCollection 2022.
citation: Kaur J, Sheoran P, Kaur S, Sarin J. Effectiveness of Warm Compression on Lumbo-Sacral Region in Terms of Labour Pain Intensity and Labour Outcomes among Nulliparous: an Interventional Study. J Caring Sci. 2020 Mar 1;9(1):9-12. doi: 10.34172/jcs.2020.002. eCollection 2020 Mar.