The Comparison of Mindfulness Based Stress Reduction(MBSR), flaxseed oil (Linum usitatissimum) and auriculotherapy on pain intensity and duration of labor in nulliparous women
The Comparison of Mindfulness Based Stress Reduction(MBSR), flaxseed oil (Linum usitatissimum) and auriculotherapy on pain intensity And duration of labor in nulliparous women
Design
Randomized clinical trial with parallel groups consisting of 4 groups including three intervention groups and one control group.
Settings and conduct
The study will be conducted at Khatam Al-Anbia Hospital and Baft County Health Centers in Kerman province and will be double blind so that patients and statistical analysts won't have any information about the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Low risk pregnancy; 40-37 weeks gestational age; Sephalic presentation; Single heart pregnancy; at least one healthy ear; one with a healthy water bag;
Non-inclusion criteria:Receiving low-dose medications within 3 hours of study initiation and lifetime;Drug addiction; being an athlete; using oxytocin to induce and accelerate childbirth; psychological problem
Intervention groups
Intervention group 1: Uriculotherapy; Intervention group 2: Flaxseed oil use; Intervention group 3: Mindfulness-based stress reduction;Control group: Routine care of labor room.
Main outcome variables
Labor pain intensity; duration of labor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191130045549N1
Registration date:2020-02-26, 1398/12/07
Registration timing:registered_while_recruiting
Last update:2020-02-26, 1398/12/07
Update count:0
Registration date
2020-02-26, 1398/12/07
Registrant information
Name
Omolbanin Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4244 1785
Email address
heydari201203@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Mindfulness Based Stress Reduction(MBSR), flaxseed oil (Linum usitatissimum) and auriculotherapy on pain intensity and duration of labor in nulliparous women
Public title
Effect of Mindfulness Based Stress Reduction (MBSR), flaxseed oil (Linum usitatissimum) and auriculotherapy on pain intensity and duration of labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria in Auriculotherapy group:
Low risk pregnancy
Being at 37th-40th week of pregnancy
Sephalic presentation
Single pregnancy
4cm dilatation and uterine contractions for 30 seconds and 2-3 contractions in 10 minutes
Ages between 18-35 years old
Body mass index ranged from 19.8 to 26.4
Literacy at least reading and writing abilities
At least one healthy ear
Having a healthy amniotic sac
Inclusion criteria in Flaxseed Oil Group and Mindfulness-Based Stress Reduction Counseling:
Age of 18-35 years
Single pregnancy
35th week of pregnancy
Literacy at least reading and writing abilities
Willingness to participate in the study
Exclusion criteria:
Receiving low-dose medications within 3 hours of study initiation and lifetime
Addiction to drugs
Being an athlete
History of infertility
Use of oxytocin to induce and accelerate labor
High-risk pregnancy
Psychological problem
Having trouble communicating
Age
From 17 years old to 36 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual randomization, drawing number method
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 Kerman University of Medical Sciences
Street address
Ghadir 3 Alley 3; Golha 2 township; Baft
City
Baft
Province
Kerman
Postal code
7856146676
Approval date
2019-11-30, 1398/09/09
Ethics committee reference number
IR.KMU.REC.1398.400
Health conditions studied
1
Description of health condition studied
Duration of delivery
ICD-10 code
ICD-10 code description
2
Description of health condition studied
intensity of labor pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Labor pain intensity
Timepoint
With the onset of labor pain, the severity of pain is measured
Method of measurement
Visual Analogue Scale of Pain
2
Description
Duration of labor
Timepoint
In 3 to 4 cm dilatation, the duration of labor is measured
Method of measurement
Partograph and checklist view and examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Mindfulness-Based Stress Reduction Counseling: In primiparous women, 8 sessions will be held two days a week and sessions will last approximately 2.5 hours and severity of pain will be measured with Visual pain ruler and duration of labor will be compared using the partograph chart at the onset of labor in the active phase and compared with the control group
Category
N/A
2
Description
Intervention group 2: auriculotherapy: At 4 cm dilatation and 40-37 weeks of gestational age, specific points on the ear are stimulated with vacarya sids (in traditional Chinese medicine, grainy labels of the plant Vakaria).
Category
N/A
3
Description
Intervention group 3: Use of flaxseed oil from Barich Company at 36-35 weeks of gestational age. Abdominal and lumbar massage with oil and training this work, three times a day
Category
N/A
4
Description
Control group: Treated in routine clinical practise