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Completed

NCT Number: NCT06297031

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

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.

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Key information

Conditions

Heat Exposure Apgar Score Duration of Labor Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heat Application

Other
  • 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.

Primary outcomes

  1. Change From Baseline labor Pain at three times

    Time frame: The pain was evaluated three times during labor

    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.

Secondary outcomes

  1. Duration of the first stage of labor

    Time frame: through study completion, an average of 1 day

    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

  2. Change From Baseline APGAR score after delivery

    Time frame: After delivery in two times at first and fifth minutes through study completion, an average of 1 day

    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

  3. Change From Baseline Fetal Heart Rate

    Time frame: 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)

    after the cervical dilatation Fetal Heart Rate was evaluated with monitor. the recommended level is 100 to 160 heart beat/minute

Sponsors and collaborators

Lead sponsor

Istanbul Demiroglu Bilim University

Other

Registry information

Official study title

The Effect of Heat Application to the Sacral Region During The First Stage of Labor On the Pain Level and the Obstetric Outcomes

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 6, 2024
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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