Determining the effect of guided mental imagery on the level of anxiety and pain in hospitalized burn patients
Design
Clinical trial with control and intervention group; parallel groups; without blinding; non-randomized and accessible; on 76 patients.
Settings and conduct
We have a small research environment (Taleghani hospital in Ahvaz), it is not possible to blind the samples, so first the control group will be studied and after their discharge, the intervention group will be sampled. We have 38 samples in each of the control groups.The method of sampling is available. For each sample of the intervention group, 10 intervention sessions will be conducted.The control group will only receive routine care. The anxiety, pain intensity and comfort of the patients were measured by the Spielberger anxiety, McGill pain and Kolkaba general comfort questionnaires before and after the intervention in the group. In the control group, the intervention is completed first and after five days according to the patients' statements by the researcher.
Participants/Inclusion and exclusion criteria
Patients with:
Age 18-60
third or fourth degree burns (with any percentage of burns)
In the second week of hospitalization
Ability to speak Persian
Smartphone and headphones;
Patients without:
History of hospitalization in the burn ward
head burn
Intervention groups
In the intervention group, in addition to routine care for each sample, 10 sessions of guided mental imagery will be performed on five consecutive days, twice a day in the patient's room. In each session, the patient listens to the educational file for about 20 minutes and closes his eyes, takes deep breaths and relaxes his muscles to completely relax. For the control group, no intervention was done and they will receive routine care.
Main outcome variables
Guided mental imagery; Anxiety ;Intensity of pain ;Quality of pain ;Burn patients; Convenience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220912055951N1
Registration date:2022-09-24, 1401/07/02
Registration timing:registered_while_recruiting
Last update:2022-09-24, 1401/07/02
Update count:0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Negin Saremi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2252 4627
Email address
neginsary@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of guided imagery on level of anxiety, pain and comfort in patients with burns
Public title
The effect of guided imagery on anxiety, pain and comfort of burn patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be in the age group of 18-60.
Have third and fourth degree burns (with any percentage of burns)
Have the ability to speak Persian
Have the desire to participate in the study
Having a smartphone and headphones
Exclusion criteria:
Have neck and face burns
Have severe hearing and vision impairment
Having mental illnesses based on self-report
Have a history of hospitalization in the burn ward
Burn patients who have undergone a graft
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
N/A
Randomization description
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 the Faculty of Nursing and Midwifery, University of Medical Sciences, Tehran Uni
Street address
Tehran University of Medical Sciences, Qods corner, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-05-01, 1401/02/11
Ethics committee reference number
IR.TUMS.FNM.REC.1401.007
Health conditions studied
1
Description of health condition studied
Burn patients
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk
Primary outcomes
1
Description
Patient anxiety score
Timepoint
At the beginning of the study, before the intervention and at the end of the intervention (the end of the fifth day)
Method of measurement
State-trait anxiety inventory
2
Description
Patient comfort level
Timepoint
At the beginning of the study, before the intervention and at the end of the intervention (the end of the fifth day)
Method of measurement
Kolkaba General Comfort Questionnaire
3
Description
Pain level of patients
Timepoint
At the beginning of the study, before the intervention and at the end of the intervention (the end of the fifth day)
Method of measurement
McGill pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: in the intervention group, in addition to routine care for each sample, 10 guided mental imagery sessions will be performed in five consecutive days, twice a day in the patient's room. During each session, the patient is directed to the mental imagery training file for about 20 minutes, listens and closes his eyes according to the sentences that will be played, takes deep breaths and relaxes his muscles until he completely relaxes.
Category
N/A
2
Description
Control group: For the control group, no intervention was performed and they will receive routine care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Burn Accidents Hospital Ayat Allah Taleghani Ahwaz
Full name of responsible person
Negin Saremi
Street address
Ayat Allah Taleghani Hospital, Mustaan St, Amaniyeh Neighborhood, Ahwaz, Khuzestan
City
Ahwaz
Province
Khouzestan
Postal code
6133911151
Phone
+98 61 3554 0256
Fax
+98 61 3554 0252
Email
htaleghani@ajums.ac.ir
Web page address
https://www.htaleghani.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Docor fotoohi
Street address
Tehran University of Medical Sciences, Qods corner, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Web page address
https://tums.ac.ir
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
Negin Saremi
Position
Nursing graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
No.22, Heydari Riseh Alley, South Ostad hasan Bana St, Resalat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1633675914
Phone
+98 21 2252 4627
Email
neginsary@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ٍEsmaeil Mohammadnejad
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Faculty of Nursing and Midwifery, Tohid Sq, East Nosrat St, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 2252 4627
Email
asreno135@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Negin Sarmi
Position
Nursing graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
No.22, Heydari Riseh Alley, South Ostad hasan Bana St, Resalat Highway
City
Tehran
Province
Tehran
Postal code
1633675914
Phone
+98 21 2252 4627
Email
neginsary@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