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NCT06214585
Effect of Intermittent Heat and Cold Therapy on Comfort During Labor
NA trial testing Intermittent heat and cold versus heat-only therapy in Labour Pain in 159 participants. Completed in 16 August 2024.
1 August 2024
Quick facts
| Lead sponsor | Tribhuvan University, Nepal |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 159 |
| Start date | 26 February 2024 |
| Primary completion | 1 August 2024 |
| Estimated completion | 16 August 2024 |
| Sites | 1 location across Nepal |
Drugs / interventions tested
- Intermittent heat and cold versus heat-only therapy
- Heat- only Therapy
Conditions studied
- Labour Pain — all drugs for Labour Pain →
- Cold Therapy — all drugs for Cold Therapy →
- Heat Therapy — all drugs for Heat Therapy →
Sponsor
Tribhuvan University, Nepal
Who can join
Adults 18 to 35, female only, with Labour Pain or Cold Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effectiveness of Alternating Heat and Cold Therapy on Pain and Labor Duration Among Primigravida: A Randomized Controlled Trial.
Lawot I, Khan I, Shrestha T, Kumar Bagga D. · · 2025 · PMID 41164031 · DOI 10.7759/cureus.93324 -
Effect of Heat Therapy on Pain During the First Stage of Labor Among Primigravid Women: A Pilot Study.
Lawot I, Khan I, Thakur N, Shrestha T. · · 2025 · PMID 39958017 · DOI 10.7759/cureus.77517
Verify or expand the search:
- PubMed search for NCT06214585
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06214585 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tribhuvan University, Nepal
- Last refreshed: 27 September 2024
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