The effect of dignity therapy on quality of life, anxiety and depression in patients with chronic obstructive pulmonary disease
Design
This is a two-group experimental research with a pre test – post test design. 62 patients with COPD will be involved in the study after obtaining informed consent. They will be randomly assigned in two groups; 31 patients as the intervention group and 31 patients will be assumed to be the control group.
Settings and conduct
dignity therapy will be performed in Khorshed Research and Educational Hospital Comprehensive Respiratory Clinic in COPD patients. This therapy is an individual psychotherapy interview. Personal interviews with patients in two or three sessions of 30 to 45 minutes will be performed.
Participants/Inclusion and exclusion criteria
Samples tend to participate in the study
the age range of 18-70 years
Have a minimum reading and writing ability (to answer the questionnaire )
grade 3 and 4 diseases based on GOLD scale
Physical ability and no cognitive impairment (based on the mental status examination questionnaire to participate in sessions and answer the questionnaire )
No major mental disorders (schizophrenia, paranoid disorders and major depression)
Intervention groups
dignity therapy group: dignity therapy is done
Control group: dignity therapy is not done
Main outcome variables
Anxiety, Depression, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211130053227N1
Registration date:2022-05-24, 1401/03/03
Registration timing:registered_while_recruiting
Last update:2022-05-24, 1401/03/03
Update count:0
Registration date
2022-05-24, 1401/03/03
Registrant information
Name
Iran tahmineh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3268 7283
Email address
tsh.nurse69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-08, 1400/11/19
Expected recruitment end date
2022-07-10, 1401/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dignity therapy on quality of life, anxiety and depression in patients with chronic obstructive pulmonary disease
Public title
The effect of dignity therapy on quality of life, anxiety and depression in patients with chronic obstructive pulmonary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Sample tend to participate in the study
age 18-70 years.
Have a minimum reading and writing ability (in order to answer the questionnaire)
grade 3 and 4 diseases based on GOLD scale
Physical ability and no cognitive impairment (based on the mental status examination questionnaire to participate in sessions and answer the questionnaire)
No major mental disorders (schizophrenia, paranoid disorders and major depression)
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study is simple with random allocation. In this way, all patients who have acceptable conditions to enter the study will be selected. Then samples randomly will be divided into intervention and control groups using the RANDOM ALLOCATION software.
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 University of Medical Sciences
Street address
Hezar Jarib Avenue, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-22, 1400/06/31
Ethics committee reference number
IR.MUI.NUREMA.REC.1400.132
Health conditions studied
1
Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J40–J47
ICD-10 code description
Chronic lower respiratory diseases
Primary outcomes
1
Description
Anxiety
Timepoint
Before and one month after intervention
Method of measurement
Hospital Scale Depression and Anxiety
2
Description
Depression
Timepoint
Before and one month after intervention
Method of measurement
Hospital Scale Depression and Anxiety
3
Description
Quality of life
Timepoint
Before and one month after intervention
Method of measurement
St. George Respiratory Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Three 30–60 minute sessions will be considered for dignity therapy implementation. The interval between sessions will be scheduled at the patients’ convenience, usually within 1 to 3 days. In the first session, a dignity therapy trained healthcare professional will introduce the objectives of the dignity therapy method, to make the participants familiar with the questions of this protocol. In the second session (24 to 48 hours later), as the implementation of this method start, the researchers guide the participants with the help of specific questions form of the dignity therapy protocol. Participants will be free to speak about important aspects of their life and anything they want to record as a memory. At the end of the recorded interview it will be transcribed and reviewed. At the third session (3 days later), the prepared text will be read to the participants and corrected if necessary. Lastly, a version of the final text will be given to the participants to share with any loved person (family members, friends, relatives, etc.). Finally, the questionnaire will be re‑done 2 weeks after dignity therapy finishing.
Category
Treatment - Other
2
Description
Control group: Received routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshed Research and Educational Hospital Comprehensive Respiratory Clinic
Full name of responsible person
Doctor Vajiheh Atashi
Street address
Ostandari Avenue , Khorshid Medical Education Center
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
nour@mui.ac.ir
Web page address
https://nour.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Mansur siavash
Street address
Hezar jarib Avenue, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Hojatollah Yousefi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jarib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
yousefi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Sharifmoradi
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar jarib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
817467346
Phone
+98 31 3286 7283
Email
tsh.nurse69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahmineh Sharifmoradi
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezar jarib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Isfahan
Province
Isfehan
Postal code
817467346
Phone
+98 31 3268 7283
Email
tsh.nurse69@gmail.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
No more information
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
No - There is not 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