Clinical trial NCT04177888: Effect of Hot Pack on Labor Pain, Duration of Labor, and Satisfaction of Primigravidae Women in Saudi Arabia
Official title: Effect of Hot Pack on Labor Pain, Duration of Labor, and Satisfaction of Primigravidae Women in Saudi Arabia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Duration of Labor
Satisfaction
Keywords: Hot pack, Labor pain, Duration of labor, Satisfaction, Primigravid women
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 91
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: experimental group received who received hot pack, which was a single-use pack filled with magnesium sulfate and water, squeezed between the hands to activate the warming effect, applied to the lower back area. The control group received routine care including Entonox.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aimed at determining the effect of hot pack on labor pain reduction and the duration of labor in comparison with routine care. Further, the study also aimed at determining the women's satisfaction with the use of hot pack and with routine care

with hypotheses: H1: Primigravid women who received hot pack in the active phase of labor will have a significantly lower mean labor pain score than those who received routine care.

H2: Primigravid women who received hot pack in the active phase of labor will have significantly shorter mean labor duration than those who received routine care.

Detailed description: Childbirth pain is the severest type of pain that women experience in their life. Therefore, effective management of labor pain is essential. There are various methods to control childbirth pain: pharmacological and non-pharmacological such as Entonox and heat therapy respectively. In most Saudi Arabian hospitals, Entonox is used as routine care, while non- pharmacological agents are rarely used. Various forms of heat therapy are effective in labor pain reduction and shortening the duration of labor. There is a dearth for studies that compare the effectiveness of the hot pack with routine care that includes use of Entonox.

Objectives

* To determine the effect of the hot pack on labor pain reduction among primigravid women.
* To determine the effect of the hot pack on the duration of labor among primigravid women.
* To determine the satisfaction of primigravid women regarding hot pack and routine care.

Methods The study was conducted in Armed Forces Hospital Southern Region, with randomized sample of 91 primigravidae with normal pregnancy in active phase of first stage of labor, with cervical dilatation of 6 - 8 cm. This randomized controlled trial consisted of two groups: the experimental group (n = 45) who received hot pack. The control group (n = 46) received routine care including Entonox. Labor pain was assessed by Visual Analogue Scale for pain intensity (VAS); duration of labor was measured by the WHO modified partograph, and women's satisfaction was assessed using a satisfaction scale. Following eligibility assessment, participants were selected and allocated to the groups randomly. After obtaining the written informed consent, the initial assessment was done; the experimental group received hot pack, and the control group received routine care until delivery. The baseline pain score was assessed before the intervention and every 30 minutes after the intervention until delivery. The duration of labor was assessed using the WHO Partograph. The women reported satisfaction two hours post-delivery using the satisfaction scale.

Results:

Before the intervention, the experimental and control group did not differ statistically in terms of labor pain score (p = .820). Post-intervention, the labor pain score was significantly lower in the experimental groups (p ≤ 0.05) compared to the control group at 30, 60, 90, 120, 150 and 210 minutes. The duration of the first, second, and third stages of labor was not significantly different among both groups (p ≥ 0.05). The overall mean satisfaction scores were significantly higher in the experimental group compared to the control group (p ≤ 0.05), the mean scores of two items, one on happiness with the care received, and the other with the delivery experience were not significantly different between both groups (p ≥ 0.05).

Conclusion:

Heat therapy, such as the hot pack is a non-pharmacological method for labor pain management. Heat therapy is effective in reducing labor pain. Although it has been not effective in shortening the duration of labor, women are satisfied with the use of hot pack. This finding could be useful in formulating policies regarding implementation of the non-pharmacological methods for labor pain management. It is essential to educate healthcare professionals regarding the benefits of heat therapy even before implementing a change.

Eligibility criteria: Inclusion Criteria:

Saudi primigravid women who:

* Have normal term pregnancy (37 to 42 weeks) and have normal onset of labor.
* Are in the active phase of the first phase of labor with cervical dilatation of 6 cm and above and admitted to labor and delivery unit at Armed Forces Hospital Southern Region (AFHSR).
* Agreed to receive routine care including Entonox inhalation or to hot pack as pain management method during labor.

Exclusion Criteria:

Saudi primigravid women who:

* Are with contraindications for hot packs (fever, area injury or inflammation, skin infection, eczema, bleeding, Deep Vein Thrombosis (DVT), edema and poor thermal regulation),
* Have complicated pregnancy (polyhydramnios, oligohydramnios, decreased fetal movement, Intrauterine Growth Restriction (IUGR), Intrauterine Fetal Death (IUFD), Ante Partum Hemorrhage (APH), history of infertility, gestational hypertension, gestational diabetes, placenta previa, and placental abruption).
* Have medical conditions such as asthma, pneumonia, chest infection, chronic disease; such as cardiovascular disease, hypertension, and diabetes.

Primary outcomes:
measure: Partograph
timeFrame: 1-8 hours during labor
measure: Satisfaction Scale
timeFrame: Used two hours post delivery for both group to assess women's satisfaction regarding the intervention and routine care
measure: Visual Analogue Scale for Pain Intensity (VAS) "change" is being assessed
timeFrame: 1-8 hours during labor
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: KSU
Study officials:
affiliation: KSU, AFHSR
name: Halimah A Alshahrani, Master
role: PRINCIPAL_INVESTIGATOR
References: