The aim of this study was to compare the efficacy of muscle relaxation and mental imagery on severity and anxiety of pain in patients with second degree burn wounds. This study is a quasi-experimental study of a clinical trial which was conducted on 135 patients admitted to Motahari hospital who were selected by convenience method. In one-month period (September 2015), 45 patients who were hospitalized in the male ward 1 & 2 and had the criteria, were placed in the control group and severity and anxiety of their pain during acute phase of their burn (first 48 hours after burn), before and after dressing change along with routine intervention (receiving morphine based on the weight before dressing), were measured. After the discharge of control group patients and admitting new patients in the male ward 1 and 2, 45 male patients in ward 1, and 45 male patients in ward 2 were given muscle relaxation technique and mental imagery technique education respectively and the severity and anxiety of their pain during acute phase of their burns (first 48 hours after burn), before and after dressing along with routine interventions (receiving morphine based on the weight before dressing), were measured. Sampling the intervention groups in male wards lasted for two months (October-November 2015). Then the severity and anxiety of the pain before and after dressing and amount of morphine consumption in the first and second days of the burn in all three groups were compared and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512194443N20
Registration date:2016-02-01, 1394/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-01, 1394/11/12
Registrant information
Name
Masoumeh Zakerimoghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 2160
Email address
zakerimo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of muscle relaxation and mental imagery on severity and anxiety of pain in patients with second degree burn wounds.
Public title
Comparing the effect of muscle relaxation and mental imagery on severity and anxiety of pain in patients with second degree burn wounds.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients should be male; patients have 2nd degree burn wounds; patients have full consciousness and be able to cooperate; patients have 20 to 45 years of age; patients have unintentional and non-inhalation burns; patients have 60-40% of their body surface area burned; patients be in the acute phase of burn (first 48 hours after burn); patients have no underlying disease (neurological disorders and numbness in the extremities, mental disorders such as; Alzheimer or memory disorders, muscle diseases, electrolyte disorders including; hyponatremia and hypocalcemia) ; patients have no known morbid anxiety problems.
Exclusion criteria: Not cooperating until the end of the intervention; treatment duration more than a month in the control group patients; the use of neuromuscular blocking agents( baclofen, dantrolene, etc.); excessive use of morphine and tranquillizers before entering the dressing room(morphine is injected by patient weight and at intervals of 4-6hours, otherwise, the patient will be removed from the sample), the need for EEᾳG surgery ( Early Excision Graft ), scartomy or fasciotomy in the severe burns phase.
Age
From 20 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Not randomized
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 of Tehran University of Medical Sciences
Street address
The sixth floor of the Central Building, St, Quds St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-10-27, 1394/08/05
Ethics committee reference number
IR.TUMS.REC.1394.1040
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T30.6
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Pain severity
Timepoint
Before and after dressing in the first and second days of the burn (acute phase of burn)
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Pain anxiety
Timepoint
Before and after dressing in the first and second days of the burn (acute phase of burn)
Method of measurement
Burn Specific Pain Anxiety Scale (BSPAS)
Intervention groups
1
Description
Control group: control group patients receive routine interventions ( receiving morphine based on the weight before dressing ) and do not interfere in this group.
Category
Treatment - Other
2
Description
Intervention group 1: patients in ward 1 were taught muscle relaxation technique along with routine interventions (receiving morphine based on the weight before dressing).
Category
Treatment - Other
3
Description
Intervention group 2: patients in ward 2 were taught mental imagery techniques along with routine interventions (receiving morphine based on the weight before dressing).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital
Full name of responsible person
Fatemeh Delfani
Street address
Rasheed Yasemi St, Above Vanak Square, Valiasr St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Scinces
Full name of responsible person
Masoumeh Zakerimoghadam
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat St, Tohid Square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Scinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing- Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Ph.D/Scientific Panel Member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
Zakerimo@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing- Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Ph.D/Scientific Panel Member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
Zakerimo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing- Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Ph.D/Scientific Panel Member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat St, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
Zakerimo@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)