This study is a clinical trial double blind, a sample size of 135 would be on the basis of sample size and sampling method is determined according to previous studies and then assigned to three groups, reflexology, acupressure, and placebo. Before the intervention for each group will be measured spielberger's anxiety form hemodynamic parameters. In the intervention group, reflexology hand in the heart reflected by the researcher, for 10 minutes (5 minutes for each hand) and acupressure points for the P6 (With 10 minutes( played. In the placebo group receive hand acupuncture on lobe of pulex with the same sample pressure for 10 minutes (5 minutes for each hand) is done. Immediately after the intervention and again half an hour later hemodynamic parameters & spilberger anxiety form will be measured
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201703287529N13
Registration date:2017-04-03, 1396/01/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-03, 1396/01/14
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
Vice chancellor for research Shahed University
Expected recruitment start date
2017-02-12, 1395/11/24
Expected recruitment end date
2017-07-15, 1396/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between hand reflexology and acupressure on anxiety and hemodynamic parameters in female patients
with acute coronary syndrome
Public title
Comparison the Effect of between hand reflexology and acupressure on the level of anxiety & hemodynamic parameters on
Patients with heart disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients’ willingness to participate in this study; Being diagnosed with the acute coronary syndrome by the physician; having no drug addiction; having no sensory disorders, infectious wounds, burns; having severe shortness of breath; lack of pacemaker pulse is less than 60; no amputation (hand); no problems or diseases of the skin at the site of intervention; cancer; history of bone fracture in the previous 2 months; lack of therapeutic massage and acupressure; without pregnancy
Exclusion criteria: being transferred to another ward; patient’s unwillingness to continue the collaboration in this study; receiving warfarin, the incidence of cardiopulmonary arrest in the past week; physicions disagreement( acute condition & loss of contiousness,..)
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Postal code
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
IR.Shahed.REC.1395.171
Health conditions studied
1
Description of health condition studied
acute coronary syndrome
ICD-10 code
I20,25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Anxiety
Timepoint
Prior to the intervention, immediately after the intervention and a half hours
Method of measurement
Speilberger's anxiety inventory
Secondary outcomes
1
Description
Blood pressure
Timepoint
Prior to the intervention, immediately after the intervention and a half hours
Method of measurement
checklist
2
Description
Respiratory rate
Timepoint
Prior to the intervention, immediately after the intervention and a half hours
Method of measurement
checklist
3
Description
Pulse rate
Timepoint
Prior to the intervention, immediately after the intervention and a half hours
Method of measurement
checklist
4
Description
Oxygen saturation
Timepoint
Prior to the intervention, immediately after the intervention and a half hours
Method of measurement
pulse oximeter
5
Description
Mean blood pressure
Timepoint
Prior to the intervention, immediately after the intervention and a half hours
Method of measurement
checklist
Intervention groups
1
Description
Hand Reflexology group :
first demographic profile questionnaire and hemodynamic parameters of the complete disease information and spilberger measurements will be recorded, and then message is done in the way that solar, plexus, Pituitary, brain, heart, intestines, vertebral column and finally adrenal and kidney for 10 minutes are triggered point wise . The intervention is performed first right hand then left hand. . Then immediately press will be half an hour Anxiety and hemodynamic parameters will be measure again and the next record will be done.
Category
Other
2
Description
The Group intervene acupressure: first demographic profile questionnaire and hemodynamic parameters of the complete disease information and spilberger measurements will be recorded, and then pressure will be done on the P6 point of two hands for5 minutes & yintang point.when the patient has a heat &pressure &stolidity sense on acupressure points confirmed the validity of points. The intervention is performed first right hand then left hand. In each hand, for 5 minutes and then immediately press will be half an hour Anxiety and hemodynamic parameters will be measure again and the next record will be done.
Category
Treatment - Other
3
Description
The placebo group who will be receive hand acupuncture on lobe of pulex with the same sample pressure. The intervention will be performed on first right hand then left hand. Anxiety and hemodynamic parameters measured again and the next record will be done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Martyr Rajaei Hospital
Full name of responsible person
Zohreh Rahmani
Street address
City
karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine Of Imam Khomeini, Tehran-Qom Express Way, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine Of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)