Determining the effect of distraction thinking and Therapeutic touch in reducing labor pain in nulliparous women
Design
The clinical trial has two intervention groups and one control group
with parallel groups
Randomized by random block method in 12 blocks of 6 from the table of random numbers
on 72 people
Settings and conduct
The research environment will be the birth preparation classes of Khalkhal city. Eligible people will be randomly assigned to one of the three groups of touch therapy, thought distraction technique, and control. The intervention group will be trained with touch therapy technique in one session and the intervention group will be trained with distraction technique (watching a movie), based on the existing protocol and in 4 sessions. The control group will also receive routine care. Then the mothers will contact the researcher upon entering the active phase of labor and the researcher will conduct the intervention in the study groups.
Participants/Inclusion and exclusion criteria
nulliparous women in the age range of 15-35 years
Pregnancy without maternal and fetal complications
Gestational age 28-32 weeks
Obtaining an average pain score from the visual pain scale
Intervention groups
The intervention group with therapeutic touch technique (the researcher will touch the mother's hands for 15 minutes with rhythmic and calm movements, without any pressure, at the beginning of uterine contractions in the active phase of labor, which is from dilation of 6 cm to entering the second stage of labor) They will receive a training session. The intervention group will participate in four sessions with distraction technique (watching a movie) which will be held weekly based on the existing protocol. The control group will receive routine care and will receive training package at the end.
Main outcome variables
labor pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151211025477N6
Registration date:2022-12-28, 1401/10/07
Registration timing:registered_while_recruiting
Last update:2022-12-28, 1401/10/07
Update count:0
Registration date
2022-12-28, 1401/10/07
Registrant information
Name
Elahe Ahmadnia
Name of organization / entity
Social determinants of health center
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 9192
Email address
ahmad@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of distraction thinking and Therapeutic touch in reducing labor pain in nulliparous women
Public title
Comparison of the effect of two methods of distraction thinking and Therapeutic touch in reducing labor pain in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
nulliparous women in the age range of 15-35 years
Pregnancy without maternal and fetal complications
Gestational age 28-32 weeks
Willingness to participate in research
Having a phone and contact number
Not having hearing and vision problems
Obtaining an average pain score from the visual pain scale
Willingness to have a natural birth at the Imam Khomeini (RA) Khalkhal Educational and Medical Hospital
Has at least middle school education
Exclusion criteria:
Indications for cesarean include: abnormal presentation of the fetus, pelvic stenosis, large fetus
Occurrence of adverse fetal outcomes
Inability to understand the scale of the pain ruler
Analgesic injection
Age
From 15 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling in this research will be done in an easy and accessible way and based on the entry criteria.Allocation of participants to 3 groups will be done by random block method in 12 blocks of 6.In such a way, two people from the first intervention group (AA), two people from the second intervention group (BB) and two people from the control group will be present in each block.Then the different states of placing these people in the blocks will be predicted and a number will be assigned to each state, then the required number of random numbers will be extracted from the table of random numbers until the study sample size is reached, and based on them, the arrangement of the participants in Groups will be determined. Matte envelopes will be prepared by the thesis advisor before sampling and will be numbered according to the sample volume. Within each envelope, the allocation of a person to one of the study groups will be determined based on the random allocation of the block. Then, at the time of entering the study, the envelope will be selected based on the participant's code and opened in their presence, and the selected person will be placed in one of the three groups.
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
The Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences، Azadi Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2022-10-28, 1401/08/06
Ethics committee reference number
IR.ZUMS.REC.1401.207
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80.9
ICD-10 code description
Single spontaneous delivery, unspecified
Primary outcomes
1
Description
Labor pain score
Timepoint
Before and after the intervention
Method of measurement
Visual analog pain scale (WONG-BAKER Pain Scale) to prevent misappropriation by the colleague present in the block who is unaware of the type and process of the intervention and the pain ruler (VAS = Visual Analogue Scale) by the mother herself once every hour in the phase Active labor (from the entry of the participating women to dilation of 6 cm until the entry into the second stage of labor) will be measured
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For.Therapeutic touch technique, a 45-minute counseling session will be held according to the protocol during pregnancy. Then, in the active phase of labor (dilation of 6 cm until entering the second stage of labor), the researcher will touch the hands of the people of this group for 15 minutes with rhythmic and calm movements (without any pressure) at the beginning of the mother's pains.
Category
Behavior
2
Description
Intervention group:For the Distraction technique (watching the movie), four 45-minute counseling sessions will be held one week apart based on the existing protocol during pregnancy. Then the researcher will play 15-minute clips (with different pre-prepared contents) according to the mother's interests in the active phase of labor (6 cm dilation until entering the second stage of labor) at the beginning of the mother's pain.
Category
Behavior
3
Description
Control group: Routine care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital (RA) - delivery room
Full name of responsible person
Leila Mikaelzadeh
Street address
Imam Rah Khalkhal educational and treatment center، Basij Square
City
Khalkhal
Province
Ardabil
Postal code
5681966675
Phone
+98 45 3242 7438
Email
m.dar@khalums.ac.ir
Web page address
https://khalums.ac.ir/dar/fa
2
Recruitment center
Name of recruitment center
Childbirth preparation class
Full name of responsible person
Ashraf Najafzadeh
Street address
Old Hospital، Shahid Mozafar Azizi Street
City
Khalkhal
Province
Ardabil
Postal code
5681761351
Phone
+98 45 3242 6802
Email
info@khalums.ac.ir
Web page address
https://khalums.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Chancellor for Research and Technology of Zanjan University of Medical Sciences, First floor, Northside Boulevard Azadi
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Fax
+98 24 3314 8300
Email
shoghli@zums.ac.ir
Grant name
Thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
10
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
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Bakhtiari
Position
Msc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Omran Posti St، Jhanbazan St
City
Khalkhal
Province
Ardabil
Postal code
5681863435
Phone
+98 45 3241 1099
Email
mhy.bakhtairi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Elahe Ahmadnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
Ahmad@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zahra Bakhtiari
Position
Msc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Omran Posti St، Jhanbazan St
City
Kalkhal
Province
Ardabil
Postal code
5681863435
Phone
+98 45 3241 1099
Email
mhy.bakhtiari@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
Yes - There is 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
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
One year after the publication of the results as an article
To whom data/document is available
Researchers
Under which criteria data/document could be used
In order to complete the studies
From where data/document is obtainable
Researcher and adviser
What processes are involved for a request to access data/document