In this non-blinded randomized clinical trial aimed to determine the effectiveness of Reflexology and Massage therapy on anxiety of patient before angiography. A total of 75 patients with an indication of angiography were referred to the department of cardiology at Hajar hospital in Shahrekord in 2013. The exclusion criteria were those not willing to continue their enrollment and patients suffering from any psychiatric or clinical diseases while undergoing this study were removed from this study. Patients were randomly assigned to 3 groups of Reflexology, Massage therapy and control, using block randomization. Two hours before angiography, patients were seen and massage therapy and reflexology were performed for the two groups. Anxiety was evaluated before and after intervention with questionnaires. We used State-Trait Anxiety Inventory at first and after intervention for the three groups. In Reflexology group patients received 15 minutes intervention for each foot and in the second group patients received 20 minutes back massage before Angiography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101719316N3
Registration date:2016-11-15, 1395/08/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Pouya Nezafati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 8888
Email address
nezafatip871@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2013-08-01, 1392/05/10
Expected recruitment end date
2013-12-01, 1392/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of massage therapy and reflexology on patients' anxiety before angiography at hajar hospital
Public title
Massage therapy and reflexology effects on anxiety of patients before undergoing angiography at hajar hospital in shahrekord - 2013
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age ≥ 18 years old; State Trait Anxiety Inventory (STAI) was scored less than 60 by each applicant. This means participants are not suffering from a severe anxiety disorder; patients were entered by their own interest; not having history of suffering from mental retardation, deafness, or blindness; no history of suffering from any psychiatric or anxiety disorder and not taking any anti-anxiety disorder drug; no history of any burn scar, rashes, trauma in the sites being massaged.
Exclusion criteria: no willing to continue their enrollment; suffering from any psychiatric or clinical problems while being under treatment for this study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellery for Research and Technology, Shahrekord University of Medical Sciences. Kashani Bld. Shahrekord. IRAN
City
Shahrekord
Postal code
Approval date
2013-05-18, 1392/02/28
Ethics committee reference number
IR.SKUMS.REC.1392.334
Health conditions studied
1
Description of health condition studied
Unstable Angina
ICD-10 code
120.0
ICD-10 code description
Unstable angina
Primary outcomes
1
Description
Anxiety change after each intervention
Timepoint
Before and 15 minutes after intervention
Method of measurement
State-Trait Anxiety Inventory questionnaire
Secondary outcomes
1
Description
Vital signs changes after intervention
Timepoint
Before and 15 minutes after intervention
Method of measurement
Clinical examination, sphygmomanometer
Intervention groups
1
Description
Reflexology technique: Reflexotherapy was conducted for each patient for 30 minutes, first for the left foot and then for the right foot (15 minutes each). Conducting reflexotherapy, first of all, the relaxation technique was used from the footstalk toward the sole (plantar surfaces) at the beginning of the session. Then, four major plantar reflexology points (solar plexus, pituitary, heart and liver) were put under pressure using the thumbs. The other reflexology areas of the plantar surface of the foot were also massaged and finally intervention was put to an end with massaging the solar plexus by the researcher. The vital signs were measured again after finishing the intervention.
Category
Treatment - Other
2
Description
Massage technique: massage therapy was performed by the same physiotherapist during the protocol and consisted of neck, shoulder and back massages for 20 minutes. The massages were initiated with light compression by the inner regions of the fingers and progressed to hard compression. Cervical traction, and mobilization in all planes (e.g., the front, back, and sides) was followed. The massage was finished with light manual compression
Category
Treatment - Other
3
Description
Control group: The control group received only routine intervention including resting for 30 minutes before angiography
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Cardiology, Hajar Hospital
Full name of responsible person
Ali Mokhtari
Street address
Hajar Hospital, Parastar St.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research - Shahrekord University of Medical Sciences
Full name of responsible person
Kamal Solati
Street address
Vice Chancellery for Research and Technology, Shahrekord University of Medical Sciencesو Kashani Blvd.
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 - 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
Ali Mokhtari
Position
MD
Other areas of specialty/work
Street address
Cardiology Group Office, Cardiology Department, Hajar Hospital
City
Shahrekord
Postal code
Phone
+98 912 888 4285
Fax
Email
mokhtaria841@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Arsalan Khaledifar
Position
Assistant Professor
Other areas of specialty/work
Street address
Cardiology Group Office, Cardiology Department, Hajar Hospital
City
Shahrekord
Postal code
Phone
+98 349175077642
Fax
Email
arsalan_khaledifar40@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Ali Mokhtari
Position
MD
Other areas of specialty/work
Street address
Cardiology Department - Hajar Hospital
City
Shahrekord
Postal code
Phone
Fax
Email
mokhtaria841@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)