Determination of hypnosis by mental imagination in reducing anxiety and labor pain of in women primipara
Design
Controlled clinical trial, with a parallel group, randomized by replacement method with sample size of 70 patients.
Settings and conduct
The present clinical trial will be done in Ommolbanin and emam reza hospital in Mashhad. After taking a written informed consent, persons will be placed in 2 groups based on random allocation. The control group will receive only routine prenatal cares. Intervention group receive mentioned intervention in addition prenatal cares. anxiety of childbirth will be measured before and after intervention with beck questionnaire. Also pain of delivery will be measured by mcgill pain questionnaire.
Participants/Inclusion and exclusion criteria
Age:18-35 years old; Primiparous; Gestational age: 28-34 weeks; single pregnancy; not having Psychology or chronic medical disease; Having average and high level of hypnotic susceptibility;
Intervention groups
In the Intervention group 5 sessions delivery room imaging with hypnosis will be done for 30 min (weekly)for the conditioning the mother in addition to usual prenatal care. Then intervention group observes the film of labor room for a 15 - minute in 28-34th weeks of pregnancy
The control group receives only routine prenatal care.
Main outcome variables
Assessment anxiety after hypnosis and watching film.
Assessment pain in two stages (dilation 4 cm; 8-4 cm).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191206045630N1
Registration date:2020-05-02, 1399/02/13
Registration timing:registered_while_recruiting
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
bita khosh kish manesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3220 1402
Email address
khoshkishmb971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-12, 1398/11/23
Expected recruitment end date
2022-02-01, 1400/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of hypnosis by mental imagination in reducing anxiety and labor pain of in women primiparous
Public title
Effectiveness of hypnosis by mental imagination in anxiety and labor pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women are Iranian and live in Mashhad.
Pregnancy is between 28 and 34 weeks.
All women are Primigravid.
Individuals will be able to answer questionnaire.
All people are literate.
Pregnancy must be a single pregnancy.
Having average and high level of hypnotic susceptibility.
Do not have Psychology or chronic medical disease.
Exclusion criteria:
Primary anxiety disorder
psychological disorders
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The research units were divided into two intervention and control groups by replacement randomization method and concealment will be done by enclosed packets.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analysis of the collected data is blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committtee of Mashhad University of Medical Sciences
Street address
Ibne Sina Street, Crossroads Doctora, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-11-12, 1398/08/21
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.093
Health conditions studied
1
Description of health condition studied
Anxiety of Childbirth
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Pain of Labour
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score Anxiety of Childbirth
Timepoint
Before intervention and after intervention by the beginning of the first phase of labour
Method of measurement
Beck anxiety questionnaire
2
Description
Labour pain
Timepoint
Cervical dilation: 4 cm and 4-8 cm
Method of measurement
Mcgill pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the Intervention group 5 sessions delivery room imaging with hypnosis will be done for 30 min (weekly)for the conditioning the mother in addition to usual prenatal cares. Then intervention group observes the film of labour room for 15 - minutes in 28-34th weeks of pregnancy.
Category
Other
2
Description
Control group: The control group receives only routine prenatal care.