Protocol summary

Study aim
The effect of hand reflexology on pain, fatigue and hemodynamic parameters in patients after coronary cardiac catheterism
Design
Two arm parallel group randomised trial with blinded outcome assessment ,design on 90 patients,
Settings and conduct
The study is done at Rejaei Hospital in Karaj, Iran. The main investigator, data collector , data analytics are kept blind to allocation groups.
Participants/Inclusion and exclusion criteria
Company in the study; Age over 18 years old; Non-emergency coronary cardiac catheterism; Without having any previous history of coronary cardiac catheterism; The absence of vascular injuries of the upper limbs and sensory-motor disorders of the hands; The absence of abnormalities such as burns, amputations and skin disorders in the hands; The absence of inter-vertebral disc herniation, low back pain and back pain; Patients tend to benefit from mental health; Having full consciousness and able to communicate; Not having addiction to drugs and alcohol
Intervention groups
In reflexology group, 2 hours after coronary cardiac catheterism, massage is done for 20 minutes (10 minutes per hand). First, the whole palm is given the massage for 2 minutes. Then is stimulated the three areas of reflecting the solar plexus, heart, pituitary. The downward pressure is applied with the thumb in the heart, pituitary, solar plexus. then circular massage is applied the same points. Fatigue VAS, pain VAS, and hemodynamic parameters are recorded by the nurse, after intervention, 4 and 6 hours after the procedure again. In the control group, only routine care is done. The Fatigue VAS, pain VAS, and hemodynamic parameters are recorded by the nurse, at times consistent with the reflexology group.
Main outcome variables
fatigue; pain; hemodynamic parameters (pulse rate; respiratory rate; blood pressure)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110912007529N17
Registration date: 2018-04-28, 1397/02/08
Registration timing: registered_while_recruiting

Last update: 2018-04-28, 1397/02/08
Update count: 0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hand reflexology on pain, fatigue and hemodynamic parameters in patients after coronary cardiac catheterism
Public title
The effect of reflexology on patients after coronary cardiac catheterism
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients’ willingness to participate in this study Age over 18 years old Non-emergency coronary cardiac catheterism Without having any previous history of coronary cardiac catheterism The absence of vascular injuries of the upper limbs and sensory-motor disorders of the hands The absence of abnormalities such as burns, amputations and skin disorders in the hands The absence of inter-vertebral disc herniation, low back pain and back pain The absence of any mental impairment Having full consciousness and able to communicate Not having addiction to drugs and alcohol
Exclusion criteria:
Patient’s unwillingness to continue the collaboration in this study The patient's death Hemodynamic instability Bleeding after coronary cardiac catheterism
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Using of the Random blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
The main investigator, data collector, data analytics are kept blind to allocation groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2017-10-30, 1396/08/08
Ethics committee reference number
IR.Shahed.REC.1396.52

Health conditions studied

1

Description of health condition studied
coronary cardiac catheterism
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
After intervention, 4 and 6 hours after coronary cardiac catheterism
Method of measurement
Visual Analoge Scale for Pain

2

Description
Fatigue
Timepoint
After intervention, 4 and 6 hours after coronary cardiac catheterism
Method of measurement
Visual Analoge Scale for Fatigue(Routen)

3

Description
Blood pressure
Timepoint
After intervention, 4 and 6 hours after coronary cardiac catheterism
Method of measurement
Sphygmomanometer

4

Description
Pulse rate
Timepoint
After intervention, 4 and 6 hours after coronary cardiac catheterism
Method of measurement
Watch

5

Description
Respiratory rate
Timepoint
After intervention, 4 and 6 hours after coronary cardiac catheterism
Method of measurement
Watch

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In reflexology group, 2 hours after coronary cardiac catheterism, massage is done in the three areas of reflecting the solar plexus, heart, pituitary. Fatigue VAS, pain VAS, and hemodynamic parameters (pulse rate; respiratory rate; blood pressure) are recorded by the nurse, after intervention, 4 and 6 hours after the procedure again.
Category
Treatment - Other

2

Description
Control group: In the control group, only routine care is done. Fatigue VAS, pain VAS, and hemodynamic parameters (pulse rate; respiratory rate; blood pressure) are recorded by the nurse, at times consistent with the reflexology group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rejaei Hospital
Full name of responsible person
Fatemeh Rahimi
Street address
Martyr Rajaei Hospital, Martyr Rajaei Ave.
City
karaj
Province
Alborz
Postal code
34570030
Phone
+98 26 3455 4484
Email
rajaei@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Vice chancellor for research, Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5521 3071
Email
Kiasalari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 6641 8580
Email
nrejeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 6641 8580
Email
nrejeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nahid Rejeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 6641 8580
Email
nrejeh@yahoo.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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Loading...