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The effect of hypnosis on anxiety and blood pressure in pregnant women with preeclampsia: a randomized controlled clinical trial

Protocol summary

Study aim
The effect of hypnosis on anxiety and blood pressure in women with preeclampsia
Design
Study of a controlled randomized clinical trial
Settings and conduct
Randomization: Random block assignment (using computer software and selecting a quadruple block) to Two groups of 22 intervention and control Research population: including pregnant women with preeclampsia under the auspices of Akbarabadi Hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: mild preeclampsia, gestational age from 28 to 32 weeks, no fetal distress, singleton pregnancy, literacy, mild to moderate anxiety score (score 14 and below), general health (low score than 23) and consent to participate in research Exclusion criteria: Depression based on information from the Beck Depression Scale (score greater than 9), participation in any educational and counseling programs related to pregnancy and childbirth anxiety before the study, consumption Psychiatric medication according to the patient's medical record, severe depression or suicidal ideation or harm to others, maternal addiction, spotting, cerclage, uncontrolled seizures, psychosis and reluctance to Continue cooperation.
Intervention groups
Intervention group: 5 individual intervention sessions will be held twice a week, online for 60-45 minutes, and at the end of each session, the audio recording file of the session will be held for each group participant. The intervention will be send, at least once a day. The interventions will be performed by a master's degree student in counseling midwifery trained, which is supervised by the research team. Interventions: In addition to routine treatment, hypnosis is received and no intervention is performed during the study
Main outcome variables
Anxiety and blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110827007422N3
Registration date: 2021-09-13, 1400/06/22
Registration timing: registered_while_recruiting

Last update: 2021-09-13, 1400/06/22
Update count: 0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Zhila Ganji
Name of organization / entity
Mazandaran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
zhila.ganji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2021-11-11, 1400/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hypnosis on anxiety and blood pressure in pregnant women with preeclampsia: a randomized controlled clinical trial
Public title
The effect of hypnosis on anxiety and blood pressure in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mild preeclampsia Gestational age from 28 to 32 weeks Absence of fetal distress Single pregnancy Literacy for reading and writing Mild to moderate anxiety score (score 14 or less) Having general health (score lower than 23) Satisfaction to participate in research
Exclusion criteria:
Depression is based on information from the Beck Depression Scale (score greater than 9) Participate in any educational and counseling programs related to pregnancy and childbirth anxiety before the study Use of psychiatric drugs (current use) according to the patient's medical record Existence of severe depression or suicidal ideation or harm to others Maternal addiction Spot stain cervical cerclage Existence of uncontrolled seizures Existence of psychosis Reluctance to continue cooperation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be divided into two groups of 22 using the blocking method. For this purpose, the samples will be divided into 11 blocks of four. The blocks will be TTCC, TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. The numbers will be randomly generated by the RANDBETWEEN command in Excel software in the range 0 to 6. Depending on the production values of one of the blocks (for production number between 0 to 1 CTTC block, for production number between 1 to 2 CTCT blocks and so on) will be selected and samples will be allocated accordingly.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done at the level of outcome assessor and evaluation at the level of analysis. The person who will evaluate the outcome and analyze the data does not know the status of the samples and does not know which participant is in the control and intervention group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2021-07-25, 1400/05/03
Ethics committee reference number
IR.MAZUMS..REC.1400.9186

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

2

Description of health condition studied
blood pressure
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Depression, Anxiety, Stress Scale (DASS-21)

2

Description
blood pressure
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Digital blood pressure gauge

Secondary outcomes

1

Description
Satisfaction with the intervention
Timepoint
immediately and one month after the intervention
Method of measurement
Visual Analog Scale: Satisfaction

Intervention groups

1

Description
Intervention group: Twice a week, individually, online (via WhatsApp) for 60-45 minutes, and at the end of each session, the audio recording of the session will be sent to each participant in the intervention group for at least one day Do hypnosis practices at home once (for 45-60 minutes). Mark the number of practices in the form that will be provided to them. In the control group, no intervention is done during the study.
Category
Behavior

2

Description
Control group: Will receive routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital Health Centers
Full name of responsible person
Dr. Mahnaz Ashrafi
Street address
Tehran, Molavi St., not far from Molavi intersection, Ferdows Garden Station
City
tehran
Province
Tehran
Postal code
۱۱۶۸۷۴۳۵۱۴
Phone
+98 21 5560 6034
Email
akbarabadi.crc@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akbar Hedayatizadeh Omran
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sciences, Moallem Square, Moallem Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3325 7230
Email
akbar-hedayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
farzaneh askari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
shirinasgari68@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
jila ganji
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenu
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
zhila.ganji@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
farzaneh askari
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nasibeh Nursin and Midwifery Faculty, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3337 4750
Email
shirinasgari68@yahoo.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
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