Effect of Hot Pack on Labor Pain, Duration of Labor, and Satisfaction of Primigravidae Women in Saudi Arabia

NCT04177888 | Completed

• 1 other identifier: E-19-4027
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Duration of Labor; Satisfaction

Keywords

Hot pack, Labor pain, Duration of labor, Satisfaction, Primigravid women

Outcome Measures

Primary Outcomes (3)

• Partograph

  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.

  1-8 hours during labor

• Satisfaction Scale

  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

  Used two hours post delivery for both group to assess women's satisfaction regarding the intervention and routine care

• Visual Analogue Scale for Pain Intensity (VAS) "change" is being assessed

  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

  1-8 hours during labor

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group with 45 participants, 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 for 30 minutes followed by 10 minutes rest then again applied for 30 minutes. This procedure was repeated till delivery.

Device: Hot Pack

Control group

NO INTERVENTION

Control group with 46 participants received the hospital routine care that included Entonox inhalation as optional labor pain management.

Interventions

Hot Pack DEVICE

It is a single-use pack filled with magnesium sulfate and water, which was squeezed between the hands to activate their warming effect. The temperature ranges between 40°C to 50°C, which is safe to use. Thus, it provided a consistent heat therapy for up to 30 minutes. They can be used directly on the skin or covered with gauze to avoid direct skin contact. Applied to the lower back area for 30 minutes, followed by 10 minutes rest between each hot pack application, then it was reapplied for another 30 minutes. This procedure was repeated till delivery.

Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

KSU

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Labor Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Halimah A Alshahrani, Master

  KSU, AFHSR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: August 1, 2018
• Primary Completion: July 25, 2019
• Study Completion: October 30, 2019
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)