An interventional study of Intermittent heat and cold versus heat-only therapy and Heat- only Therapy in Labour Pain, Cold Therapy and Heat Therapy, sponsored by Tribhuvan University, Nepal. Completed at 1 site in Nepal. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Tribhuvan University, Nepal · Not applicable, Interventional, and Supportive care
Summary of the Study Childbirth is one of the most significant and complex experiences in any mother's life. According to a study, labour pain ranges from mild to severe and is felt throughout the body, particularly in the lower abdomen, vagina, and around the waist. The mean pain perception of the prurient as assessed by the Visual Analog scale (VAS) was 7.0 with a range of 1.2-10.0. In a study, 50% of parturients rated labour pain as severe (VAS > 7.1). The majority of the respondents 86.4% desired some form of pain relief. Pain relief during labor is a crucial component of the labor process. Non-drug techniques for alleviating labor pain focus on psychological and physical discomfort elements. A study in Panjab was performed to assess the effectiveness of heat therapy on the lower back among women in labor pain during the first stage of labor and found that heat therapy reduces the severity of pain in the first stage of labor. A study performed in India found that intermittent heat and cold therapy successfully shorten the first and second stages of labor's duration and pain. The purpose of the study is to compare the impact of intermittent heat and cold therapy with heat-only therapy on comfort and duration of labor among primigravida women at a Bharatpur hospital in Nepal.
A quantitative research approach will be adopted and the research design will be a true experimental pretest posttest design. It will be conducted among 150 low-risk primigravida women aged 20 to 35 years with a gestation of 37-41 weeks of pregnancy admitted to the maternity of Bharatpur Hospital, Chitwan Nepal who are anticipated to deliver spontaneously. The participants will be divided into 50 in each 3 groups. One group will receive intermittent heat and cold therapy, another group will receive heat-only therapy and one group will be the control group. The tool will be a standard tool which are Visual Analog Scale (VAS) and Childbirth Comfort Questionnaire (CCQ). All the ethical clearance will be obtained before collecting data from Sharda University, Nepal Health Research Council, and Bharatpur Hospital. Informed consent will be taken from all the participants and their rights, privacy, confidentiality, and comfort will be maintained. The participants can withdraw from the study at any time without giving any explanation. The data will be organized and entered into Statistical Package of Social Sciences (SPSS) version 16 for analysis. The data will be analyzed according to the objectives of the study by using descriptive and inferential statistics.
Heat Only Therapy A 2-liter rubber hot water bag will be utilized to provide heat to the lower back of primigravida women during the first stage of labor. The water in the bag will be maintained at a temperature of 40-42ºC. The application of heat will last for 20 minutes, and it will be repeated every hour until the cervix is fully dilated. To prepare the hot water, tap water will be boiled in a stainless steel pot until it reaches 70ºC. Before filling the hot water bag, its temperature will be verified using a laboratory thermometer. The bag will then be covered with a towel and applied to the laboring women, ensuring the heat is tolerable for her. If the temperature falls below the specified range, another hot water bag will be made ready for replacement. Intermittent Heat \& Cold Therapy During the first stage of labor (from 4-5 to 10 cm of cervical dilation) for the experimental group, a cyclical method of alternating heat and cold application will be used on the lumbosacral and lower abdominal area of the laboring women. The process involves applying a hot pack with a temperature range of 38-40°C on their lower abdomen and low back for 30 minutes during contractions and a relaxing period using a 2-litre rubber hot water bag.
Subsequently, reusable ice packs typically contain water, covered with a towel and with a temperature range of 0-5°C will be applied to the same areas for 10 minutes. After a 30-minute interval, the heat application will be reapplied, and this alternating heat and cold cycle will be repeated throughout the first stage of the laboring process. After interventions 4-5, 7-8 and 9-10 cm of cervical dilation, we will assess the comfort including pain level and after 10 cm of cervical dilation, duration will be calculated to identify the total duration of first stage of labor
395 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 159 is above the median of 100 across 325 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Tribhuvan University, Nepal is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Low-risk primigravida are those pregnant women who are between the ages of 18 to 35 years old admitted to Bhartpur hospitals and anticipated normal delivery.
Exclusion criteria ('no any complication')
There will be one group that will be receiving warm water application on the mother's back and then receiving ice pack application on the same region.
Procedure: Intermittent heat and cold versus heat-only therapy · Procedure: Heat- only Therapy
This group of mothers will receive a warm application by hot water bag only on her back
Procedure: Intermittent heat and cold versus heat-only therapy · Procedure: Heat- only Therapy
This group will receive just standard care as hospital protocol
for the experimental group, a cyclical method of alternating heat and cold application will be used on the lumbosacral and lower abdominal area of the laboring women. The process involves applying a hot pack with a temperature range of 38-40°C on their lower abdomen and low back for 30 minutes during contractions and a relaxing period using a 2-litre rubber hot water bag. Subsequently, reusable ice packs typically contain water, covered with a towel and with a temperature range of 0-5°C will be applied to the same areas for 10 minutes. After a 30-minute interval, the heat application will be reapplied, and this alternating heat and cold cycle will be repeated throughout the first stage of the laboring process.
hot water bag will be used to provide heat to the lower back of primigravida women during the first stage of labor. The water in the bag will be maintained at a temperature of 40-42ºC. The application of heat will last for 20 minutes, and it will be repeated every hour until the cervix is fully dilated.
Level of Comfort
It will be measured using Childbirth Comfort Questionnaire.The Childbirth Comfort Questionnaire (CCQ) was developed and tested in 2002-2003. Face validity was accomplished by a panel of experts: midwives, obstetricians, labor and delivery nurses and women who had given birth. The instrument has a 0.71 Cronbach's (sample size n = 64). The instrument is administered twice during labor: latent \& active phase. To score, reverse code the negative responses and total the sum. Higher totals mean higher comfort.
Time frame: 1 to 2 hours of intervention
Duration of Labor
Duration of labor will be measured using a partograph. The initiation of labor time to completion labor process will be recorded in the partograph. At the end of the first labour stage, the total labour hour will be caculated and mentioned as mean duration which will be compared with other data
Time frame: 4 to 5 hours
Level of labor pain
A Visual Analogue Scale will be used as the pain rating scale used for the first time in 1921 by Hayes and Patterson. There is no pain" on the far left and "the most intense pain imaginable" on the far right. In between these two extremes, words such as mild, moderate, severe, and very severe pain are assigned to each 2 cm distance on the line, respectively.
Time frame: 1 to 2 hours of intervention
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tribhuvan University, Nepal