Determination effects of cold and heat therapy on labor pain intensity and duration of labor in nulliparous women who referred to Iran haspital
Design
105 women were recruited allocated to the cold therapy.heat therapy and the control group.A comparative experimental design was used to achieve the objecyives of the study.In order to select the research units the samples were placed one day in cold therapy,heat therapy and control group respectively. Inclusion criteria were samples who willingly participated or excluded from the study.vaginal examination which assessed based on dilation of the cervix. if they met a dilation of less than 4 cm criteria,they ere recruite as heat and cold therapy or control group.In the study there is not rendomization and blinding.
Settings and conduct
This study is done in Iran Iran-Shahr Hospital. The sample size was 105 patients in three groups: Cold Therapy, heatTherapy and Control.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
Age: 18 to 35 years; At the beginning of the active phase of labor (dilation of 3 to 4CM); Gestational age: 37 to 41 weeks; Single pregnancy pregnancy
;Cephalopods
Exit criteria:
. Gestational hypertension; Poly and Oligo-Hydramonus with ultrasound
; Reducing fetal movements; IUGR; Fetal death; Any complications experienced during the study; unwillingness to continue the intervention
Intervention groups
Heat and cold therapy were applied as interventions in this study. the heat therapy group received warm water bags over low back and suprapubic area while in the cold therapy group ice bag applied ti woman"s low back and perineal area. no intervention was conducted in the control group. Intensity of labor pain compared in the three groups.
Main outcome variables
The effect of intervention on the severity of labor pain and the length of delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180624040219N1
Registration date:2018-09-19, 1397/06/28
Registration timing:prospective
Last update:2018-09-19, 1397/06/28
Update count:0
Registration date
2018-09-19, 1397/06/28
Registrant information
Name
Mahnaz Didevar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3722 6579
Email address
mahnaz.didevar@irshums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare effects of cold and heat therapy on labor pain intensity and duration of labor in nulliparous women who referred to Iran haspital
Public title
The effect of curative and thermotherapy on the severity of labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Age 18 to 35 years
2. At the beginning of the active phase of labor (dilatation 3 to 4CM)
3- Gestational age 37- 41 weeks
4- Single-crowned pregnancy
5- Cephalic sedation
Exclusion criteria:
1- Diagnosis of mental and anatomical disorders (psychosis, schizophrenia, uterine anomalies, pelvic stenosis
2. Chronic known disease (heart disease, pulmonary, hypertension, diabetes
Skin diseases (any lesion, inflammation and eczema in the area of thermal therapy and cold therapy
Gestational hypertension
Cephalopods10. Poly and Oligo-Hydramonus with ultrasound
Reduce fetal movements12- IUGR13. Fetal death1
Rupture of curtains for more than 12 hours.
Discontinuity of the head of the fetus with the pelvis
Abnormal heartbeat patterns
History of chronic pelvic pain
Infertility record
Any complications experienced during the study (abnormal placenta, abnormal position of the embryo, umbilical cord prolapse)
unwillingness to continue the intervention
Use of any medication or analgesia
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:
105
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iranshahr University of Medical Sciences
Street address
Balooch Blvd
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Approval date
2017-06-19, 1396/03/29
Ethics committee reference number
iR.IRSHUMS.REC.1396.3
Health conditions studied
1
Description of health condition studied
The effect of Thermal Therapy and Cold Therapy on the severity of labor pain and delivery time
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Initial Outcome Assessment of labor pain according to vas
Timepoint
Before intervention, dilatation of 3 cm, dilatation 5-6 cm, dilatation of 10-9 cm, and second stage of labor
Method of measurement
Visual Analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: In the heat therapy group, the level of heat in the bag is controlled by the forearm of the researcher's hands,the heat bag cover by tine cloth the first stage is placed in the lower back and in the second stage in the supraPubic and Its duration depends on the desire of woman. The acceptable duration for a first-time heat therapy is at least 60 minutes and in the second stage, at least 5 minutes. The temperature of the hot water bottle is adjusted between 38-40. The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, mean heart rate, type of delivery, perineum status and maternal satisfaction will be assessed.
Category
Treatment - Devices
2
Description
Intervention group: Second intervention group: Cold Therapy. Before of any intervention, the severity of the pain in the 4 cm dilatation is measured by showing a graded ruler. the Ice Bag cover by thin cloth and put on back in the first stage and it put in second stage in the perineal and suprapubic . The acceptable duration for cold therapy is at least 60 minutes in the first stage and at least 5 minutes in the second stage. The temperature of the ice bag is between 0 to -5 degrees.The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, type of delivery, perineum status and maternal satisfaction will be assessed.
Category
Treatment - Devices
3
Description
Control group: For the control group, the usual care is done.The severity of pain will be measured in the dilatation 3-4, 7-8, 10-9 and the second stage of delivery with the Visual Analogue Scale (VAS). The duration of the first, second and third stages of labor, the first and fifth minute APGAR, type of delivery, perineum status and maternal satisfaction will be assessed.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranshahr University of Medical Sciences, Iranshahr, Iran Hospital
Full name of responsible person
Mahnaz Didehvar
Street address
Shahid Moradi Boulevard, Iran Hospital
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3722 6579
Email
mahnaz.didevar@irshums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Tahmine Salehian
Street address
balooch Blvd
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0485
Email
tahmine.salehian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr 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
Iranshahr University of Medical Sciences
Full name of responsible person
Mahnaz Didehvar
Position
Facuty of Iranshahr university of Medical scinces
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Balooch Blvd
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0481
Email
didevar.m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Mahnaz Didehvar
Position
Faculty
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Balooch Boulvar
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0481
Email
didevar.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Mahnaz Didehvar
Position
faculty
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Balooch Boulvar
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0481
Email
didevar.m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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