Heat Application to the Sacral Region and Pain Level During the First Stage of Labor

Labor Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06297031
• Other study ID #: 2020/20
• Status: Completed
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: February 2024
• Source: Istanbul Demiroglu Bilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 30, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Apgar Score
• Duration of Labor
• Heat Exposure
• Labor Pain

Intervention

Other:
• heat application
• Thermophore Application: Before the application, the thermophore was wrapped in a towel to prevent skin damage. Studies in the literature indicate that the surface temperature of the thermophore should be 38-45 °C. For this reason, water with a temperature of 70°C when measured with a thermometer was added into the thermophore. Similarly, studies in the literature indicate that thermophore application should be applied for 10-30 minutes. Therefore, the application takes 20 minutes. The researcher stayed with the woman for 20 minutes.

Locations

Country	Name	City	State
Turkey	Demiroglu Bilim University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline labor Pain at three times	It will be assessed three times during the first stage of the labor with Number Rating Scale. Pain intensity measured on a Number Rating Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.	The pain was evaluated three times during labor
Secondary	Duration of the first stage of labor	The time between the start of the pain expressed by the woman and the moment she was taken to the delivery table was calculated by the researcher and called the first stage of labor. The researcher used clock to calculate the duration	through study completion, an average of 1 day
Secondary	Change From Baseline APGAR score after delivery	The scale is designed to determine the need for urgent intervention by assessing the condition of the newborn in order to reduce neonatal morbidity and mortality rates. A score of 0 represents the lowest level of functionality, while a score of 10 indicates optimal health. A score below 4 indicates that the newborn has significant respiratory distress that requires urgent medical attention	After delivery in two times at first and fifth minutes through study completion, an average of 1 day
Secondary	Change From Baseline Fetal Heart Rate	after the cervical dilatation Fetal Heart Rate was evaluated with monitor. the recommended level is 100 to 160 heart beat/minute	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)