Comparison of the Effectiveness of Relaxation and Cognitive Counseling Intervention on Hypertension and Quality of Life in Pregnant Women with Hypertension
Study and comparison of the cffectiveness of relaxation and cognitive intervention on blood pressure and quality of life in pregnant women with hypertension
Design
A randomized, controlled, one blind, placebo-controlled clinical trial
Settings and conduct
This study will be conducted in Fasa city. Sixty pregnant women will be selected from the offices of Fasa urban family physicians and randomly assigned into three groups of intervention, Cognitive counseling relaxation training and control groups. The study is a one blinded, meaning that participants are not aware of the interventions of other groups. Quality of life and blood pressure of pregnant women before and after the intervention will be measured for all groups and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with hypertension in the second 3 months of pregnancy
Intervention groups
Intervention group 1: Relaxation counseling group; Intervention group 2: Cognitive counseling group and Control group receiving no intervention
Main outcome variables
Hypertension and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191028045259N1
Registration date:2020-04-21, 1399/02/02
Registration timing:registered_while_recruiting
Last update:2020-04-21, 1399/02/02
Update count:0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Sanaz Atef
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
sa.atef68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Relaxation and Cognitive Counseling Intervention on Hypertension and Quality of Life in Pregnant Women with Hypertension
Public title
Comparison of the Effectiveness of Relaxation and Cognitive Counseling Intervention on Hypertension and Quality of Life in Pregnant Women with Hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The women under study should be pregnant and hypertensive
Be literate.
Exclusion criteria:
disabling diseases
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
for randomization we prepare 60 cards and divide into 3 groups of 20. The first 20 cards of number 1 are written. The second card of number 2 and the Third 20 cards of number 3 are written ad put in the envelope. We ask the pregnant woman with hypertension to choose one of the cards. Finally, the number on the selected card represents the group where the patient will be placed.
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
Ebnsina Ave., Jahad Blvd., Kerman city
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2019-11-02, 1398/08/11
Ethics committee reference number
IR.KMU.REC.1398.344
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I11
ICD-10 code description
Hypertensive heart disease
Primary outcomes
1
Description
Hypertension
Timepoint
Before and after intervention
Method of measurement
Mercury barometer
2
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
WHOQOL-Bref Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: "Relaxation" In this method, the intervention is performed in 4 90-minute sessions. in These sessions explain the impact of relaxation on maternal mental health, improvement of sleep, maternal nutrition, and its effect on the process of delivery and on postpartum recovery, and on being effective in breastfeeding and reducing postpartum depression.At each session, the target group is practicing relaxation. and will repeat at intervals between intervention sessions at home.
Category
Behavior
2
Description
Intervention group 2: Cognitive counseling Cognitive counseling is provided in 8 to 10 one-hour sessions. 8 group sessions and 2 individual sessions to discuss specific topics. In this way the following will be taught to the participants. -Definition and Importance of Cognitive Therapy -The Cognitive Discovery Method of Pregnancy-Related Cognitive Disorders -Patients' Cognitive Evaluation of the Effectiveness of Cognitive Techniques on Cognition's and Their Changes -Reviewing future thinking and behavior change programs
Category
Behavior
3
Description
Control group: There is no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Family doctors' offices in Fasa city
Full name of responsible person
Firouzeh Mirzaei
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
74616-86688
Phone
+98 71 5331 4068
Email
sa.atef68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firouzeh Mirzaei
Street address
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi Blvd., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Firouzeh Mirzaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firouzeh Mirzaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firouzeh Mirzaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Haft Bagh Alavi Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
f_mirzaee@kmu.ac.ir
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