Effect of Hot Pack on Labor Pain, Duration of Labor, and Satisfaction of Primigravidae Women in Saudi Arabia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- King Saud University
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Partograph
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Partograph
Time Frame: 1-8 hours during labor
The partograph is a universal tool to assess the progress of labor, it included graphical information with three main components; fetal condition, the progress of labor, and maternal condition. The researcher used the progress of labor component in the partograph to calculate the duration of labor in minutes.
Visual Analogue Scale for Pain Intensity (VAS) "change" is being assessed
Time Frame: 1-8 hours during labor
It is a one item scale that involves a horizontal or vertical line which starts either with 0 to 10 cm. Zero is no pain and 10 is the worst or intolerable pain. the interpretation is zero no pain, 1 - 3 cm mild pain, 4 - 6 cm moderate pain, 7 - 9 cm severe pain, and 10 cm intolerable or worst pain possible. baseline labor pain assessed, then VAS used every 30 minutes to assess labor pain till delivery
Satisfaction Scale
Time Frame: Used two hours post delivery for both group to assess women's satisfaction regarding the intervention and routine care
A Likert-type scale with five points. The scale descriptions: (5) very satisfied, (4) satisfied, (3) neither satisfied nor dissatisfied, (2) dissatisfied, and (1) very dissatisfied
Secondary Outcomes
No secondary outcomes reported
Investigators
Halimah Ali Alshahrani
Midwife, Principal Investigator
King Saud University