Labor PainNCT04177888
Effect of Hot Pack on Labor Pain, Duration of Labor, and Satisfaction of Primigravidae Women in Saudi Arabia
A study testing Hot Pack in people with Labor Pain and Duration of Labor, run by King Saud University at 1 site in Saudi Arabia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Duration of Labor, Satisfaction
- What is being tested?
- Hot Pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Labor Pain, Duration of Labor, Satisfaction
- Being tested
- Hot Pack
- Keywords
- Hot pack, Labor pain, Duration of labor, Satisfaction, Primigravid women
- Medical subject headings
- Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot PackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 1-8 hours during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Aug 2018
- Primary completion25 Jul 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halimah Ali Alshahrani, King Saud University
- Investigators
- Halimah A Alshahrani, Master, Principal investigator, KSU, AFHSR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177888
- Sponsor's protocol ID
- E-19-4027
- Status last verified
- Nov 2019
- First submitted
- 22 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hot Pack on Labor Pain, Duration of Labor, and Satisfaction of Primigravidae Women in Saudi Arabia
- ClinicalTrials.gov ID
- NCT04177888
- Acronym / sponsor ID
- E-19-4027
- Conditions
- Labor Pain, Duration of Labor, Satisfaction
- Keywords
- Hot pack, Labor pain, Duration of labor, Satisfaction, Primigravid women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Hot PackExperimental 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. |
| Control group | No intervention | –Control group with 46 participants received the hospital routine care that included Entonox inhalation as optional labor pain management. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot PackIt 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. | Device | Experimental group |
Primary outcome
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No. individual participant data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halimah A Alshahrani, Master principal investigator
KSU, AFHSR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot Pack in people with Labor Pain and Duration of Labor, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partograph (time frame: 1-8 hours during labor). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.