Determining the effect of reflexology foot massage on pain and anxiety caused by suction in hospitalized patients
Design
A clinical trial with a control group, single, randomized groups, on 36 patients, a simple randomization method was used for randomization.
Settings and conduct
Many studies around the world have been conducted to investigate the effect of foot reflexology massage on pain and anxiety. In this study, the effect of foot reflexology massage on pain and anxiety caused by suction in mechanically ventilated patients was investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Being hospitalized for at least 24 hours
2- The pationt is under mechanical ventilation and needs suction.
3- Do not use sedatives and anti-anxiety drugs at least three hours before and during suction.
4- GCS above
5- Do not hit the head.
Exclusion criteria:
1- The need for other therapeutic intervention during the study
2- Awakening and sudden exit of the endotracheal tube
3. Disorder in the patient's hemodynamic status during the study
Intervention groups
In the intervention group, foot reflexology massage is performed by a trained person for 10 minutes for each foot and a total of 20 minutes for both feet. The patient's level of anxiety and pain is measured once immediately after the suction and before the start of the foot reflexology massage based on the available questionnaires, and one time after the end of the 20-minute foot reflexology massage. In the control group, foot reflexology massage is not performed and the patient's pain and anxiety level are measured once immediately after suction and once after 20 minutes.
Main outcome variables
pain; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210331050800N1
Registration date:2021-04-26, 1400/02/06
Registration timing:retrospective
Last update:2021-04-26, 1400/02/06
Update count:0
Registration date
2021-04-26, 1400/02/06
Registrant information
Name
negin mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 6788
Email address
neginm137@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology massage on pain and anxiety of suctioning of patients under mechanical ventilation
Public title
The effect of foot reflexology massage on pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization for at least 24 hours
The patient is under mechanical ventilation and needs suction.
Stability of hemodynamic status (blood pressure (140-100 mm Hg) - heart rate (60-100) - respiration rate (12-12) - SPO2 (90% or higher))
Do not use sedatives and anti-anxiety drugs at least three hours before and during suctioning.
Patient age over 18 years and less than 75 years
GCS above 8
The patient is not addicted to alcohol, drugs and cigarettes.
The health of the soles of the feet has been confirmed in the absence of corns, fungal skin problems, previous scars, and neuropathy.
Do not hit the head.
Exclusion criteria:
Need to perform other therapeutic interventions while studying
Awakening and sudden exit of the endotracheal tube
Impaired hemodynamic status of the patient during the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by available method and based on inclusion criteria. Randomization is done by simple random method and by lottery method. Write the word test on one sheet of paper and the word control on another sheet of paper and place it in a container. Draw for the first patient to determine if they are in the test or control group. For example, if the first person is in the test group, the next patient will be in the control group or vice versa. And so the rest of the samples are taken.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of aja university of medical sciences
Street address
Shariati St., Kaj St., Molly Al-Movahedin Organizational Alley
City
Tehran
Province
Tehran
Postal code
1613917111
Approval date
2021-03-02, 1399/12/12
Ethics committee reference number
IR.AJAUMS.REC.1399.247
Health conditions studied
1
Description of health condition studied
The effect of foot reflexology massage on pain and anxiety caused by suction in mechanically ventilated patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score obtained based on COPT instrument
Timepoint
Pain measurement immediately after suction (before intervention) and after 20 minutes of reflexology foot massage
Method of measurement
COPT tool
2
Description
Anxiety score obtained based on FAS instrument
Timepoint
Anxiety measurement immediately after suction (before intervention) and after 20 minutes of reflexology foot massage
Method of measurement
FAS tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Reflexive foot massage is performed for 10 minutes for each foot (20 minutes in total).
Category
Other
2
Description
Control group: There is no intervention in this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان خانواده
Full name of responsible person
نگین مهرابی
Street address
Shariati St., Kaj St., Molly Al-Movahedin Organizational Alley
City
Tehran
Province
Tehran
Postal code
1613917111
Phone
+98 21 8855 6682
Email
neginm137@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zashk
Street address
نوشتار مبدأ چهار راه فاطمی، خیابان اعتمادزاده auto_awesome آیا منظور شما این است: چهارراه فاطمی، خیابان اعتمادزاده 33 / 5000 نتایج ترجمه Fatemi crossroads, Etemadzadeh street
City
Tehran
Province
Tehran
Postal code
1613917111
Phone
+98 21 8855 6682
Email
neginm137@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Negin Mehrabi
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati St., Kaj St., Molly Al-Movahedin Organizational Alley
City
Tehran
Province
Tehran
Postal code
1613917111
Phone
+98 21 8855 6682
Email
neginm137@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Negin Mehrabi
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati St., Kaj St., Molly Al-Movahedin Organizational Alley
City
Tehran
Province
Tehran
Postal code
1613917111
Phone
+98 21 8866 5586
Email
neginm137@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Negin Mehrabi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati St., Kaj St., Molly Al-Movahedin Organizational Alley
City
Tehran
Province
Tehran
Postal code
1613917111
Phone
+98 21 8855 6686
Email
neginm137@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
No - There is not 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