Comparison of the effect of reflexology and spiritual care on pain severity, anxiety, sleep quality and coping strategies of patients with chest trauma
Comparison of the effect of reflexology and spiritual care on pain severity, anxiety, sleep quality and coping strategies of patients with chest trauma.
Design
A single-center double blinded randomized controlled trial, without placebo.
Settings and conduct
This study will be conducted on 80 patients with chest trauma, hospitalized at Modarres Hospital of Saveh.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Multiple trauma patients with blunt and penetrated chest trauma based on injury severity score; communicating skills; complete consciousness after surgery; belief to the religion of Islam; willingness to cooperate in the study and sign the informed consent form; not having skin disease with the feet involvements; not having diabetes with peripheral nerve involvement and sensory disorders in the feet; not having acute infections or ulcers in the feet; 18 to 65 years old patients.
Exclusion criteria:
Unwillingness to cooperate in the study; experience of spirituality counseling classes for the past 6 months to a year; past year's crisis situations (divorce, death of close relatives and serious accidents)
Intervention groups
First intervention group: In the first intervention group, reflexology will be performed at a slowly, with a regular rhythm and with a depth of 1 to 3 mm for 3 consecutive days.
Second intervention group: In the second intervention group, the samples will receive spiritual care in groups of 4 to 6 peoples. The educational content will be held in three 45-minute session in the Surgery Department training room in 3 days, with a day interval.
Main outcome variables
Severity of pain; severity of anxiety; quality of sleep; adaptation strategy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161223031522N12
Registration date:2019-11-02, 1398/08/11
Registration timing:registered_while_recruiting
Last update:2019-11-02, 1398/08/11
Update count:0
Registration date
2019-11-02, 1398/08/11
Registrant information
Name
Vahid Naseri Salahshour
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
v.naserisalahshour@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of reflexology and spiritual care on pain severity, anxiety, sleep quality and coping strategies of patients with chest trauma
Public title
The effect of reflexology and spiritual care on pain, anxiety, sleep quality and adaptation of patients with chest trauma
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple trauma patients with blunt and penetrated chest trauma based on injury severity score.
Communicating skills.
Complete consciousness after surgery.
Belief to the religion of Islam.
Willingness to cooperate in the study and sign the informed consent form.
Not having chronic pain (migraine headaches, low back pain, sciatica pain, rheumatic pain, arthritis pain, etc.).
No skin disease with feet involvements.
Not having diabetes with peripheral nerve involvement and sensory disorders in the feet.
Not having acute infections or ulcers in the feet.
Not having coagulation disorders.
18 to 65 years old patients.
Exclusion criteria:
Unwillingness to cooperate in the study.
Experience of spirituality counseling classes for the past 6 months to a year.
Past year's crisis situations (divorce, death of close relatives and serious accidents).
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The samples divided into first and second intervention groups using simple random allocation. In this study, a dice will used as randomization tool and for making the sequences the paired numbers will be assigned to the first intervention group and the odd numbers will be assigned to the second intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blinded study in which the data analyzer and the participants did not know the random allocation in the first and second intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
South Sheikh Bahaei Ave., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.BMSU.REC.1398.206
Health conditions studied
1
Description of health condition studied
Chest trauma
ICD-10 code
S29.7
ICD-10 code description
Multiple injuries of thorax
Primary outcomes
1
Description
Severity of pain based on visual analogue scale
Timepoint
Before and after intervention
Method of measurement
visual analogue scale
2
Description
Anxiety score in Spielberger inventory
Timepoint
Before and after intervention
Method of measurement
Spielberger anxiety inventory
3
Description
Sleep quality score in Pittsburgh index
Timepoint
Before and after intervention
Method of measurement
Pittsburgh sleep quality index
4
Description
Adaptation score in Lazarus and Folkman's questionnaire
Timepoint
Before and after intervention
Method of measurement
Lazarus and Folkman's adaptation questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: in the first intervention group, reflexology will be performed at a slowly, with a regular rhythm and with a depth of 1 to 3 mm for 3 consecutive days.
Category
Lifestyle
2
Description
Second intervention group: in the second intervention group, the samples will receive spiritual care in groups of 4 to 6 peoples. The educational content will be held in three 45-minute session in the Surgery Department training room in 3 days, with a day interval.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Elham Farhadi
Street address
Modarres Hospital, Motahhari St., Azadi Sq.
City
Saveh
Province
Markazi
Postal code
3819693345
Phone
+98 86 4222 3026
Email
info@savehums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhosein Alishiri
Street address
South Sheikh Bahaei Ave., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri-Salahshour
Position
MSc. of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Morteza Hoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
South Sheikh Bahaei Ave., Mollasadra St., Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8806 8923
Email
sm_hosseini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vahid Naseri-Salahshour
Position
MSc. of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
vahidnaseri1994@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared.
When the data will become available and for how long
36 months after the publishing of the results.
To whom data/document is available
Researchers in academic and scientific institutions.
Under which criteria data/document could be used
Scientific purposes.
From where data/document is obtainable
Vahid Naseri-Salahshour
vahidnaseri1994@yahoo.com
What processes are involved for a request to access data/document