A Comparative Study of the Effectiveness of Trans-diagnosis With Relaxation Therapy on Psychological Symptoms, Parental Beliefs About Neonatal Intensive Care Unit, Adaptation to Mother Role and Social and Occupational Adjustment in Parents of Premature Neonates Admitted to Neonatal Intensive Care Unit
A Comparative of the Effectiveness of Trans-diagnosis With Relaxation Therapy on Psychological Symptoms, Parental Beliefs About Neonatal Intensive Care Unit (NICU), Adaptation to Mother Role and Social and Occupational Adjustment in Parents of Premature Neonates Admitted to Neonatal Intensive Care Unit (NICU)
Design
A clinical trial with a control group, with parallel, randomized groups, on 36 parents, will use the quadratic randomized blocking method for randomization.
Settings and conduct
The study population in this study will include all parents whose infants were admitted to the Neonatal Intensive Care Unit (NICU) in 2020. The sample of this study will be selected from all parents whose infants are hospitalized in the Neonatal Intensive Care Unit (NICU) of hospitals affiliated to Shiraz University of Medical Sciences. To conduct this research, after the approval of the ethics committee of Kermanshah University of Medical Sciences and its registration in the clinical trial (IRCT), hospitals affiliated to Shiraz University of Medical Sciences will be referred.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: having a baby admitted to the neonatal intensive care unit (NICU)
Main exclusion criteria: Absence from two sessions of treatment sessions
Intervention groups
18 participants will receive Trans-diagnosis treatment (experimental group) and 18 participants will receive a booklet and CD of relaxation techniques (control group).
Main outcome variables
depression, anxiety, emotional regulation strategies, self-compassion, parental beliefs about neonatal intensive care unit (NICU), adaptation to mother role, work and social adjustment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160103025817N5
Registration date:2020-11-25, 1399/09/05
Registration timing:prospective
Last update:2020-11-25, 1399/09/05
Update count:0
Registration date
2020-11-25, 1399/09/05
Registrant information
Name
Ali Akbar Parvizi Far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 330 8692
Email address
aa.parvizif@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Effectiveness of Trans-diagnosis With Relaxation Therapy on Psychological Symptoms, Parental Beliefs About Neonatal Intensive Care Unit, Adaptation to Mother Role and Social and Occupational Adjustment in Parents of Premature Neonates Admitted to Neonatal Intensive Care Unit
Public title
A Comparative Study of the Effectiveness of Trans-diagnosis With Relaxation Therapy on Psychological Symptoms, Parental Beliefs About Neonatal Intensive Care Unit, Adaptation to Mother Role and Social and Occupational Adjustment in Parents of Premature Neonates Admitted to Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Premature baby survival
The baby is single
Conscious desire and satisfaction of parents to participate in research
If the mother is a participant in the study, she should not be hospitalized at the same time
Non-abuse of drugs, alcohol and psychotropic drugs, and other drugs (based on participants' comments)
Non-development of chronic mental disorders and personality disorders structured according to the principles of the clinical interview
Have a minimum cycle education
Scoring higher than the cut-off point in the Beck Depression and Anxiety Inventory
Not receiving other psychological services at the same time
Exclusion criteria:
Failure to answer the questions of the questionnaires used in the research (at least 5% of the questions in each questionnaire)
Absence from two sessions of treatment
Unwillingness to continue the process of any of the treatments
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will first be selected by purposive sampling method and then will be assigned to the four groups using a random quadratic blocking method. The participants are divided into four blocks (9 people in each block). In this method, usually, the number of people assigned to each group is almost equal and blocks are formed based on the desired variables, and within each block, half of the people are involved and half are considered as controls. The main purpose of this method is to balance the number of participants in each group. The four blocks of the intervention groups (A) and control (B) will be defined (AABB, ABAB, ABBA, BBAA, BABA, BAAB) and will be written on the number cards 1 to 6. The cards are then placed in an envelope. Finally, the cards are randomly selected and a random string is created from the sequence of selected cards. The participants of the intervention and control group enter the research based on this sequence.
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 Kermanshah University of Medical Sciences
Street address
Kermanshah, Shahid Beheshti Blvd., Building No. 2, University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.KUMS.REC.1399.809
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F33.1
ICD-10 code description
Major depressive disorder, recurrent, moderate
2
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
bepression score in Beck Inventory
Timepoint
Pre-test, post-test and follow-up
Method of measurement
Beck Depression Inventory
2
Description
anxiety score in Beck Inventory
Timepoint
Pre-test, post-test and follow-up
Method of measurement
Beck Anxiety Inventory
3
Description
score emotion regulation strategies
Timepoint
pre-test, post-test, follow-up
Method of measurement
emotion regulation Gross and John questionnaire
4
Description
self-compassion score
Timepoint
pre-test, post-test and follow-up
Method of measurement
self-compassion questionnaire
5
Description
score of parents' beliefs about the neonatal intensive care unit
Timepoint
pre-test, post-test and follow-up
Method of measurement
Questionnaire of parents' beliefs about neonatal intensive care unit
6
Description
score of adaptation to mother role (For mothers)
Timepoint
pre-test, post-test and follow-up
Method of measurement
questionnaire of adaptation to the mother role
7
Description
score work and social adjustment
Timepoint
pre-test, post-test and follow-up
Method of measurement
work and social adjustment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The structure of meta-diagnostic treatment sessions will be based on Barlow (2011) model, which includes 8 sessions of 90 minutes and will be performed weekly. The structure and techniques of each session will be as follows: Session 1: Psychological training and motivation to treat emotional problems, Session 2: Emotional awareness training, Sessions 3 and 4: Correction of cognitive assessments, Sessions 5 and 6: Emotionally influenced behaviors and Emotional Avoidance, Sessions 7 and 8: Situational and Endogenous Exposure.
Category
Behavior
2
Description
Control group: Participants in this group will receive a training booklet and relaxation technique CDs on a scheduled basis. At first, practical training will be provided to them by a trained specialist. They will then be given a booklet and CD of relaxation training. This treatment is performed by the participants themselves at home. The time required to perform this training does not take more than 5-7 minutes at a time.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zeinabiyyeh Hospital of Shiraz
Full name of responsible person
Dr. Reza Bahrami
Street address
Shiraz-Holy Defense Intersection-Hazrat Zeinab Therapeutic Training Center
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3726 6811
Fax
+98 71 3726 5252
Email
sajjadreisi1373@gmail.com
2
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr. Reza Bahrami
Street address
Shiraz, Zand St., Namazi Square, Namazi Educational and Medical Center
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
sajjadreisi1373@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah, Shahid Beheshti Blvd., Building No. 2, University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
4562388887
Phone
+98 83 3383 4180
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
دانشگاه علوم پزشکی کرمانشاه
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. AA. parvizifard
Position
Assistant Professor of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, School of Medicine, Razi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8239
Email
Parvizia@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. A.A parvizifard
Position
Assistant Professor of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, School of Medicine, Zakaria Azi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8239
Email
Parvizia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. AA parvizifard
Position
Assistant Professor of Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, School of Medicine, Zakaria Razi Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8239
Email
Parvizia@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD