The purpose of this study is to investigate the effect of hand and foot massage on anxiety and vital signs of patients with acute coronary syndrome. Inclusion criteria: acute coronary syndrome; exclusion criteria: unwillingness to continue cooperation. The simple sampling will be done on eligible patients at second day of hospitalization. Before any act, the patient will be informed about keeping his/her information private, participating in the study voluntarily and the aims of the study. Then the written consent form will be completed by the patient. The patients will be randomly classified to one of the intervention(35 patient) or control groups(35 patient) by selecting one of two envelope( the name of “intervention group” is written and kept in one envelope the name of “control group” is written and kept in another). 30 minutes before the beginning of the intervention, the Spielberger's Anxiety Questionnaire will be completed and patients' vital signs will be checked and registered in vital signs checklist and also skin allergy test will be done for the intervention group. If the patient has no skin allergy, she/he will be provided with a 20-minute hand and foot massage (5 minutes to each extremity). We use stroking techniques and surface stroke. The vital signs of patients will be checked immediately after the intervention and 60 and 90 minutes after massaging. Then the patient will refill Spielberger's Anxiety Questionnaire 15 minutes after the massage therapy. In the control group, the vital signs will be checked as scheduled and then the Spielberger's Anxiety Questionnaire will be completed. The main outcome will be anxiety and vital signs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070134830N1
Registration date:2017-08-11, 1396/05/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-11, 1396/05/20
Registrant information
Name
Seyed Alimohammad Hasheminia
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
hasheminiaali@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research and technology affairs of Shahrekord University of Medical Sciences.
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-08-16, 1396/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hand and foot massage on anxiety and vital signs of patients with acute coronary syndrome.
Public title
The effect of massage on anxiety and vital signs.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18 years; The patient is alert; specialist physican diagnosis of ACS;The patient should not have severe anxiety disorder; The patient is not being treated with warfarin; The patient should not have a pulse of less than 60 beats per minute or more than 110 beats per minute; In the last 72 hours there should be no respiratory interruption; The patient should not have a pacemaker; The patients should not have limb implantation; Lack of dangerous arrhythmias in the patient; The patient should not have coagulation disorders; The patient should not have history of bone fracture in the last two months; Patient should not have deep vein thrombosis; Patient should not have dialysis fistula in the upper limb; Not taking hypnotics, opiates, benzodiazepines and alcohol and spinal anesthesia by the patient within the last 4 hours; The patient should have a tendency to participate in the research project; Having healthy massage areas.
Exclusion criteria: Unwillingness to continue cooperation
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study the samples are selected randomly using two envelopes. It is written in an envelope of the intervention group and inside the other control group, and the patient by selecting one of the envelopes divided in one of the two intervention or control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.SKUMS.REC.1396.83
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome.
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
30 minutes before the intervention and 15 minutes after intervention.
Method of measurement
Spielberger's Anxiety Questionnaire.
2
Description
vital signs
Timepoint
30 minutes before the intervention, immediately after the intervention and 60 and 90 minutes after massaging.
Method of measurement
Blood pressure (pressure gauge) , pulse and respiration (by the researcher, in 1 min).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 minutes before the intervention the Spielberger's Anxiety Questionnaire will be completed and patients' vital signs will be checked and registered in vital signs checklist and skin allergy test will be done. If the patient had no skin allergy, she/he will be provided with a 20-minute massage on hand and foot (5 minutes to each extremity). We use stroking techniques and surface stroke for massaging. The vital signs of patients will be checked 30 minutes before the intervention, immediately after the intervention and 60 and 90 minutes after massaging; then the patient refills Spielberger's Anxiety Questionnaire 15 minutes after the massage therapy.
Category
N/A
2
Description
In the control group, the vital signs will be checked as scheduled and then the Spielberger's Anxiety Questionnaire will be completed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Zahra Ghasemi
Street address
Hajar hospital, Parastar street, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Shahrekord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
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 of Shahrekord University of Medical Sciences
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
Shahrekord University of Medical Sciences
Full name of responsible person
Zahra Ghasemi
Position
Msc student in Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
zahraghasemi.g@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Seyyed Ali Mohammad Hasheminia
Position
Master's Degree In Surgical Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 0061
Fax
Email
hasheminiaali@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Zahra Ghasemi
Position
Msc student in Nursing
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
00
Fax
Email
zahraghasemi.g@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)