Protocol summary

Study aim
Comparison of the effect of infrared belt with hot water bag on pain intensity and duration of first stage of labor in primiparous women
Design
Clinical trial with control group, parallel groups, randomized without blinding
Settings and conduct
The study site is Mashhad Hospital, Mashhad. Sampling is easy. In both groups, the intervention was performed in two cycles for 20 minutes, in the lumbar region of mothers in the first stage of labor, in 4-5 cm dilation and then in 6-7 cm dilation. The duration of the contractions, the severity of the contractions, are recorded and recorded every 10 minutes every half hour. The mean score of pain intensity in the intervention groups was measured by the researcher in the first stage of labor, immediately after the uterine contraction, before the first intervention cycle, and immediately after the two intervention cycles, and at the end of the first phase of labor, ie, 10 cm dilation of the cervix. . .
Participants/Inclusion and exclusion criteria
Inclusion criteria: be Iranian. • The age of delivery is 18-35 years. • Be literate. • be primiparous. • singleton is. • Show fetal head peak. • Exclusion criteria: • Have drug and alcohol addiction and tobacco. Mother discontinued from continuing research. Emergency caesarean section is indicated for any reason. • Affected by medical conditions
Intervention groups
This study included two intervention groups (infrared belt and hot water bag) and one control group.
Main outcome variables
Severity of labor pain, duration of first stage of labor

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190805044446N1
Registration date: 2019-12-03, 1398/09/12
Registration timing: retrospective

Last update: 2019-12-03, 1398/09/12
Update count: 0
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
fateme dastjerd
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4263 5925
Email address
dastjerdf941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-27, 1398/05/05
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of infrared belt with hot water bag on pain intensity and duration of first stage of labor in primipara women
Public title
The effect of heat therapy on pain intensity and duration of labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian.• The age of delivery is 18-35 years.• Be literate.• Sign a written consent form.• be primiparous.• Be monotonous.• Show fetal head peak.• The fetal head fits the mother's pelvis.Gestational age is 38 weeks to 42 weeks based on the first day of the last menstrual period or ultrasound of the first trimester of pregnancy.Estimated weight of the fetus using Johnson's law or ultrasound after 32 weeks will be between 25,000 to 4,000 grams.Spontaneous labor has begun (4-5 cm dilatation with at least two contractions of 20 or 30 seconds and more within 10 minutes).• The intensity of labor pain should be greater than 3 on the visual pain scale (10 cm ruler).Do not have speech-auditory or dialect problems that impede communication with the researcher.• Do not have drug and alcohol and tobacco addiction.• Has not had a psychiatric or psychologist experience, medication or hospitalization due to mental illness during the past year.• Has not been under major stress for the past 6 months.• Not be affected by medical conditions.• Do not have midwifery problems.• Has no history of surgery on the uterus or cervix.• Have not used the medicine prescribed by your doctor, midwife or herbal medication for the past 24 hours to start labor pain.• The mother's oral temperature should not be equal to or greater than 38 ° C.• Do not have severe anxiety.• Do not have scars, scratches, burns, eczema or lumbar lesions that prevent heat treatment.
Exclusion criteria:
Mother to discontinue continuing research.Emergency caesarean section is indicated for any reason.Use oxytocin to induce labor or accelerate labor.Use narcotics, Entonox, numbness.• There are signs of fetal distress.• Observe any abnormal cases, such as hypertonic contractions or rapid tibial systolic dysfunction and disturbances in the vital signs of the mother and others• Observe any possible side effects of the infrared belt (skin burns, increased maternal body temperature, abnormal fetal heart sound, abnormal uterine contractions, maternal intolerance to the infrared belt or hot water bag)• Mother's intolerance of infrared belt or hot water bag• Other cases
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 162
Randomization (investigator's opinion)
Randomized
Randomization description
Block of six, which is done by computer.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a three-group study

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad School of Nursing and Midwifery, doktora squar, Mashhad .
City
Mashhad
Province
Razavi Khorasan
Postal code
1062807413
Approval date
2019-07-13, 1398/04/22
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.029

Health conditions studied

1

Description of health condition studied
Birth pain
ICD-10 code
--
ICD-10 code description
--

Primary outcomes

1

Description
Severity of pain with shortened McGill questionnaire
Timepoint
At the beginning of the study, after the first intervention, after the second intervention, at the end of the first phase
Method of measurement
shortened McGill questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Infrared Belt: Two cycles of 20 minutes intervention by infrared belt in first stage of labor for 40 minutes total
Category
Treatment - Devices

2

Description
Intervention group 2: Hot water bag,two cycles of 20 minutes intervention by hot water bag in first stage of labor for 40 minutes total
Category
Treatment - Devices

3

Description
Control group: Third group Control group: Routine care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Om albanin hospital
Full name of responsible person
fateme erfanian
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
---
Phone
+98 51 5118 5756
Fax
+98 51 5517 1999
Email
erfanianf@mums.ac.ir
Web page address
https://www.um.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
erfanian fateme
Street address
Doctoral crossroads
City
mashhad
Province
Razavi Khorasan
Postal code
--
Phone
+98 51 4263 5735
Fax
+98 51 4263 5735
Email
Erfanianf@mums.ac.ir
Web page address
https://www.um.ac.ir/
Grant name
Evidence-Based Care Research Center
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
erfanian fateme
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Doctoral crossroads
City
mashhad
Province
Razavi Khorasan
Postal code
--
Phone
+98 51 4263 5735
Fax
+98 51 4263 5735
Email
Erfanianf@mums.ac.ir
Web page address
https://www.um.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
erfanian fateme
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Doctoral crossroads
City
mashhad
Province
Razavi Khorasan
Postal code
--
Phone
+98 51 4263 5735
Fax
+98 51 4263 5735
Email
Erfanianf@mums.ac.ir
Web page address
https://www.um.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
erfanian fateme
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Doctoral crossroads
City
mashhad
Province
Razavi Khorasan
Postal code
--
Phone
+98 51 4263 5735
Fax
+98 51 4263 5735
Email
Erfanianf@mums.ac.ir
Web page address
https://www.um.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main outcome is shared
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Unable to access data
From where data/document is obtainable
Dastjerdf941@mums.ac.ir
What processes are involved for a request to access data/document
--
Comments
--
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