Investigating the effect of emotional focus therapy on the perceived stress caused by marital relationships in patients with burn wounds who referred to wound clinics in Arak city in 2023
Effect of emotional focus therapy on perceived martial stress in patient with burn wounds
Design
In this study, the effect of an emotion-focused intervention on perceived stress from marital relationships in burn injury patients is investigated. Forty patients are enrolled and randomly assigned to intervention and control groups. The study does not have a waitlist control phase and is not blinded.
Settings and conduct
40 patients with burn wounds referring to wound clinic located in Arak city are selected based on the conditions of entry into the study and after obtaining consent to participate in the research, they will be randomly divided into two intervention and control groups. The couples are divided into two groups. Individuals are provided in the form of emotion-oriented intervention group therapy in the counseling and psychotherapy clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria
Without any psychotherapy history in the previous six months
Having burn wounds
Being married and having a marital relationship in the last six months
Without any mental history disorders
Being between 18 - 45 years old
Without any amputated limb.
Exclusion Criteria: pregnancy-Experiencing severe marital disputes
Intervention groups
Intervention group: Exciting group intervention: The members of the intervention group participated in 8 face-to-face training and group counseling sessions, one session per week and the duration of each session was between 100 and 120 minutes. The counseling sessions were on Thursdays from 8 am to 11 am In the wound clinic of Arak city, phone follow-up was done to make an appointment
Main outcome variables
Perceived stress from marital relationships in patients with burn wounds
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230413057895N1
Registration date:2024-07-08, 1403/04/18
Registration timing:retrospective
Last update:2024-07-08, 1403/04/18
Update count:0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Alireza Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3223 0622
Email address
alrz.mns99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-27, 1402/08/05
Expected recruitment end date
2023-12-26, 1402/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of emotional focus therapy on the perceived stress caused by marital relationships in patients with burn wounds who referred to wound clinics in Arak city in 2023
Public title
Investigating the effect of emotional focus therapy on the perceived stress caused by marital relationships in patients with wounds
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Without any psychotherapy history in the previous six months
Having burn wounds
Being married and having a marital relationship in the last six months
Without any mental history disorders
Being between 18 - 45 years old
Without any amputated limb.
Exclusion criteria:
Experiencing severe marital disputes
pregnancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients was done by random allocation sampling in two stages.In this way, it was used to create a random sequence of two groups; in such a way that one of the study groups was considered to be lion and the other group was considered to be line and based on the desired sample size, a coin was tossed and people were divided into two random allocation groups. Sealed non-transparent envelopes were used to hide the random allocation.In this way, based on the sample size of the research, a number of envelopes with aluminum coating were prepared and each of the random sequences created was recorded on a card and the cards were placed in the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes was numbered in the same order. Finally, the lid of the letter envelopes was glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes was opened and the assigned group of that participant was revealed.
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 Isfahan Islamic Azad University
Street address
Arqavanie-Isfahan Islamic Azad University
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Approval date
2023-08-21, 1402/05/30
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.214
Health conditions studied
1
Description of health condition studied
Perceived stress caused by marital relationships of burn wound sufferers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Perceived stress caused by marital relationships of burn wound sufferers
Timepoint
Measuring marital stress with the Stockholm questionnaire before the intervention, after the intervention, one month after the intervention
Method of measurement
Stockholm Marital Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In this project, the effect of emotion-oriented intervention on the perceived stress caused by marital relations in patients with burn wounds is investigated. 40 patients are divided into two intervention and control groups of 20 people using a table of random numbers. Simple randomization uses a table of random numbers to perform simple random selection. In the table of random numbers, each person participating in the project, regardless of their age and gender, is given a unique number. Then, random selection happens in the form of a lottery and the numbers are drawn by a third party.In this way, twenty participants will form the control group and the other twenty will form the intervention group. The members of the intervention group will participate in 8 face-to-face training and group counseling sessions. One meeting is held every week. The time of each session will be between 100 and 120 minutes. And after 8 weeks, the results will be discussed and analyzed statistically. The control group will not participate in the meetings and undertake not to receive any psychological treatment during this time period. The intervention and control groups will be contacted by telephone on Fridays every week. It is established that they will answer the questions of the questionnaire. The obtained results are categorized and analyzed with spss software.
Category
Lifestyle
2
Description
Control group: no intervention was done in the control group and only pre-test and post-test were taken from them. Also, from all the research subjects, a follow-up test and completion of the questionnaires was done after one month after the intervention in order to comply with ethical issues. After the completion of the research, a training guide in the form of a DVD in the field of controlling perceived stress from relationships was given. Marriage was also given to the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Wound Clinic
Full name of responsible person
Alireza Mansouri
Street address
Imam Khomeini Street
City
Arak
Province
Markazi
Postal code
3813847519
Phone
+98 86 3223 0622
Email
alirezamansori3550@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Majid Toqiani
Street address
East Ji Street-Arqavanie-University Boulevard
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2179
Email
Research@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Alireza Mansouri
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini Street
City
Arak
Province
Markazi
Postal code
38138-47519
Phone
+98 86 3223 0622
Email
alirezamansori3550@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Mansouri
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini street
City
Arak
Province
Markazi
Postal code
3813847519
Phone
+98 86 3223 0622
Email
alirezamansori3550@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Mansouri
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Khomeini street
City
Arak
Province
Markazi
Postal code
3813847519
Phone
+98 86 3223 0622
Email
alirezamansori3550@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