Determining the effect of art therapy on anxiety and quality of life following pregnancy loss
Design
Clinical trial with control and intervention groups, randomized with blocking methodSample number 60 (30 people in each group)
Settings and conduct
Individuals enter the study if they wish and have inclusion criteria.
At the beginning of the referral, the prenatal grief scale of Putin et al will be completed by clients and included in the study if the grief is confirmed.
Random allocation will be done by blocking method.
Samples will then be informed of the subject and the informed consent form will be completed. And they complete the demographic, mourning, anxiety, and quality of life questionnaires. Samples will be divided into 4 90-minute sessions of two sessions per week of painting and pottery as planned, and the anxiety and mourning questionnaires will be completed after two sessions of art therapy and after the course is completed. Eight weeks after the intervention, all three questionnaires will be completed again.
During the intervention period, no intervention will be performed in the control group except for routine medical care following pregnancy loss.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Having a history of miscarriage or stillbirth in the last 6 weeks
2. Minimum literacy
3. Willingness to participate in the study
4. Confirm grief by PGS questionnaire
5. Residence in Tehran
Exclusion criteria:
1. Mental illness
2. Severe psychiatric reactions that require referral to psychiatry and basic interventions.
3. Current use of antidepressants
4. Unwillingness to participate in the study
5. Failure to attend at least one art therapy session
Intervention groups
Art Therapy Recipient Group
Control group (not receiving art therapy)
Main outcome variables
Quality of life; anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200104046002N1
Registration date:2020-01-07, 1398/10/17
Registration timing:registered_while_recruiting
Last update:2020-01-07, 1398/10/17
Update count:0
Registration date
2020-01-07, 1398/10/17
Registrant information
Name
masumeh zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 5913
Email address
masumezahmatkesh64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of art therapy on anxiety and quality of life following pregnancy loss
Public title
The effect of art therapy on anxiety and quality of life following pregnancy loss
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of miscarriage or stillbirth in the last 6 weeks
Minimum literacy
Willingness to participate in the study
Mourning confirmation by PGS questionnaire
Residence in Tehran
Exclusion criteria:
Developing mental illness
Severe psychological reactions that require referral to psychiatry and basic interventions.
Current use of antidepressants
Unwillingness to participate in the study
Failure to attend at least one art therapy session
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
This will be done by blocking method. For this purpose, the four blocks selected will be assigned to the intervention group letter A and the control group letter B. The 6 possible modes will be written on separate cards and assigned to each card a number (from one to six), then the numbers will be written on the paper and randomly removed. Until the expected sample number is completed. Sequence concealment will be carried out using envelopes in a package such that one of the letters is placed in the order specified and then the envelope is closed and provided to the researcher. The process of random allocation and concealment is performed by the statistical consultant.
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 Tehran University of Medical Sciences
Street address
No 55,12th Ave, first dehghanvilla.
City
Karaj
Province
Alborz
Postal code
3139913939
Approval date
2019-09-04, 1398/06/13
Ethics committee reference number
IR.TUMS.FNM.REC.1398.102
Health conditions studied
1
Description of health condition studied
Anxiety after pregnancy loss
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Mourning after losing pregnancy
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Quality of life following pregnancy loss
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Quality of Life: According to the World Health Organization Questionnaire, the short version of 26 questions indicates a score of 26 to 59 inadequate quality of life, 60 to 89 average quality of life, and a score of 90 to 130 appropriate quality of life.
Timepoint
At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention
Method of measurement
WHO questionnaire, short version 26 questions
2
Description
Explicit anxiety: 20 to 31 mild anxiety score, 32 to 42 moderate to low anxiety score, 43 to 53 moderate to high anxiety score, 54 to 64 moderately severe anxiety, 65 to 75 severe anxiety score, and 76 to 80 very severe anxiety score, respectively. Show.
Timepoint
At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention
Hidden anxiety: 20 to 31 mild anxiety score, 32 to 42 moderate to low anxiety score, 43 to 52 moderate to high anxiety score, 53 to 62 moderately severe anxiety, 63 to 72 severe anxiety score, and 73 to 80 very severe anxiety scores, respectively. Show.
Timepoint
At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention
Mourning: Earning a score of 92 or higher on an overall score of 34 or higher on the Active Mourning subscale or a score of 30 or higher on the Hard Coping subscale and a score of 27 or higher on the Despair subscale indicates a high degree of mourning.
Timepoint
At first, after two sessions of intervention, at the end of the intervention and 8 weeks after the intervention
Method of measurement
prenatal grief scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Samples of this group will be divided into 4 sessions of 90 minutes, two sessions per week of painting and pottery, and the anxiety and mourning questionnaire will be completed after two sessions of art therapy and after the end of the course. Eight weeks after the intervention, all three questionnaires will be completed again.
Category
Rehabilitation
2
Description
Control group: Control group: Samples In this group, there will be no art therapy intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo Hospital
Full name of responsible person
Masoume Zahmatkesh
Street address
Railway Square, Behdari Street
City
tehran
Province
Tehran
Postal code
12299
Phone
+98 21 5565 8500
Email
Hosp_baharloo@tums.ac.ir
Web page address
http://medicine.tums.ac.ir/baharlou
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zahmatkesh
Street address
No 55,12th Ave, first dehghanvilla.
City
Alborz
Province
Alborz
Postal code
3139913939
Phone
+98 26 3464 5913
Email
masumezahmatkesh64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zahmatkesh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 55,12th Ave, first dehghanvilla.
City
karaj
Province
Alborz
Postal code
3139913939
Phone
+98 26 3464 5913
Email
masumezahmatkesh64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masumeh Zahmatkesh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 55, 12th Ave, first Dehghanvilla.
City
Alborz
Province
Alborz
Postal code
3139913939
Phone
+98 26 3464 5913
Fax
Email
masumezahmatkesh64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masumeh Zahmatkesh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 55, 12th Ave, first Dehghanvilla.
City
Alborz
Province
Alborz
Postal code
3139913939
Phone
+98 26 3464 5913
Fax
Email
masumezahmatkesh64@gmail.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