Determining the effectiveness of Acceptance and Commitment Therapy (ACT) on body image fear and marital satisfaction in patients with ostomy.
Design
An interventional study with control and parallel groups, with randomization , Phase 3 study will perform on 70 patients with ostomy.
Settings and conduct
This study will perform on 70 patients with ostomy referred to Ghaem Hospital in Mashhad. Patients will be randomly divided into control and intervention groups. Blinding wouldnot be perform. Patients in the intervention group will have 8 sessions of consultation with the therapist, and in the control group, without any counseling sessions, body image fear and Enrich's marital satisfaction questionnaires will be completed for each patient in the intervention and control groups.
Participants/Inclusion and exclusion criteria
All married people having an ostomy and fully satisfaction to enter the project.
Intervention groups
In the intervention group, patients are trained in the Acceptance and Commitment Approach Protocol (ACT) for 8 sessions and body image and marital satisfaction questionnaires are completed before and after the sessions.
In the control group, people complete body image and marital satisfaction questionnaires without any counseling session.
Main outcome variables
Fear of body image
Marital satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N37
Registration date:2021-05-16, 1400/02/26
Registration timing:prospective
Last update:2021-05-16, 1400/02/26
Update count:0
Registration date
2021-05-16, 1400/02/26
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Acceptance and Commitment Therapy (ACT) on body image and marital satisfaction of patients with ostomy
Public title
The effectiveness of acceptance and commitment therapy (ACT) on ostomy patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having an ostomy
Married
Exclusion criteria:
Attending therapeutic sessions or psychotherapy training concurrently
Taking psychotropic drugs or drug abuse for the past six months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
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 Ferdowsi University of Mashhad
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.HSU.REC.1398.028
Health conditions studied
1
Description of health condition studied
Rectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
Description
Fear of body image
Timepoint
At the beginning of the study (before the intervention) and after 8 counseling sessions in the intervention group and without consultation in the control group
Method of measurement
Fear of body image questionnaire
2
Description
Marital Satisfaction
Timepoint
At the beginning of the study (before the intervention) and after 8 counseling sessions in the intervention group and without consultation in the control group
Method of measurement
Enrich Marital Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, patients are trained in the Acceptance and Commitment Approach (ACT) Protocol for 8 sessions. Explaining the concept of acceptance and its difference with the concept of failure, identifying the values of patients' lives and specifying and focusing on these values, possible internal and external barriers to pursuing values and preparation to deal with them are expressed. Before and after the sessions, body image and marital satisfaction questionnaires are completed.
Category
Behavior
2
Description
Control group: In the control group, patients without any counseling sessions would complete, body image and marital satisfaction questionnaires before and after the time duration of the sessions with the intervention group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Ghaem Hospital
Full name of responsible person
Monire Pourfarahani
Street address
Ahmad abad AVE, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3801 2469
Email
farahanim4900@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad Ferdowsi University
Full name of responsible person
Hossein Share
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3879 6773
Email
hoshareh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Hossein Share
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
د Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3879 6773
Email
hoshareh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Hossein Share
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychology
Street address
Ferdowsi University of Mashhad, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3879 6773
Email
hoshareh@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