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Effect of hand massage on anxiety in ophthalmology surgery using local anesthesia

Protocol summary

Summary
Anxiety is common disorders of patients especially before surgery. If anxiety is not controlled, can cause psychological and physiological reactions and will affect the process of surgery and recovery. Therefore, this study examined effect of hand massage on anxiety in ophthalmology surgery using local anesthesia. In this experimental study, 52 patients who have been ophthalmology surgery using local anesthesia were studied. Patients were assigned randomly to an experimental group (hands massage before surgery, n= 27 patients) and control group (no hand massage, n=25 patients). Patients in the Experimental group had a hand massage for 5 minutes before surgery. Two researchers trained by stroke and scrubbing method performed all the massages. In stroke and scrubbing method, olive oil is applied to the patients' hands and each hand is massaged just before surgery for 5 minutes (each hand 2 minutes and 30 seconds). Massage was including a series of scrubbing movements down from the wrist to the fingers using large circular stretching strokes, and stroke movements in palm and back of hands. In addition, palpation, stretching, and circular range of motion were done on the fingers. All study parameters(Anxiety level by Eshpil Berger standard questionnaire, blood pressure, pulse rate and respiratory rate) were measured at the 2 time in both group: before and after the experimental group received the hand massage. Data was analyzed by chi-square, independent samples T test and paired T test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107056955N1
Registration date: 2011-07-27, 1390/05/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-07-27, 1390/05/05
Registrant information
Name
Roghieh Nazari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 1919
Email address
r.nazari@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hand massage on anxiety in ophthalmology surgery using local anesthesia
Public title
Effect of hand massage on anxiety in ophthalmology surgery using local anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 20-60 years old; pharmacological surgery using local anesthesia by the some surgeon using the same technique performed between 9-12AM. Exclusion criteria: hormone therapy; sedative before surgery; were diagnosed as having a disease that elevates blood level of Epinephrine, Cortisol and blood sugar; had hands with injury, erratum, edema and pain in hands; psychological disorders or receiving psychological drugs; uncontrolled cardiovascular diseases.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 52
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Gangafrooz Ave, Babol, Iran
City
Babol
Postal code
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
88274412

Health conditions studied

1

Description of health condition studied
Eye surgery
ICD-10 code
H00-H59
ICD-10 code description
Diseases of the eye and adnexa

2

Description of health condition studied
Complication of local anesthesia
ICD-10 code
y40-y84
ICD-10 code description
Surgical and other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure

Primary outcomes

1

Description
Anxiety levels
Timepoint
Before massage, after massage
Method of measurement
Eshpil Berger standard questionnaire

Secondary outcomes

1

Description
Vital signs ( blood pressure, pulse rate and respiratory rate)
Timepoint
Before massage, after massage
Method of measurement
Digital machine and observation

Intervention groups

1

Description
Patients in the Experimental group had a hand massage for 5 minutes before surgery. Two researchers trained by stroke and scrubbing method performed all the massages. In stroke and scrubbing method, olive oil is applied to the patients' hands and each hand is massaged just before surgery for 5 minutes (each hand 2 minutes and 30 seconds). Massage was including a series of scrubbing movements down from the wrist to the fingers using large circular stretching strokes, and stroke movements in palm and back of hands. In addition, palpation, stretching, and circular range of motion were done on the fingers.
Category
Treatment - Other

2

Description
No massage or other treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hefdah Shahrivar Hospital of Amol
Full name of responsible person
Sima Khazaeinajad
Street address
Operation room, Hefdah Shahrivar Hospital, Hefdah Shahrivar Ave, Amol
City
Amol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Babol University of Medical Sciences
Full name of responsible person
Dr. Amrollah Mostafazadeh
Street address
Vice chancellor for research, Babol University of Medical Sciences, Gangafrooz ave, Babol
City
Babol
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, Babol 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
Babol Uniersity of Medical Sciences
Full name of responsible person
Roghieh Nazari
Position
Faculty member
Other areas of specialty/work
Street address
Amol nursing and midwifery school, Fayazbakhsh ave, Taleb Amoli ave, Amol
City
Amol
Postal code
Iran
Phone
+98 12 1222 1919
Fax
Email
r.nazari@mubabol.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Roghieh Nazari
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Amol Nursing and Midwifery school, Fayazbakhsh ave, Taleb Amoli ave, Amol
City
Amol
Postal code
Phone
+98 12 1222 1919
Fax
Email
r.nazari@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol Uiversity of Medical Sciences
Full name of responsible person
Roghieh Ahmadzadeh
Position
Student of Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery School, Fayyazbakhsh Ave, Talebe Amole Ave, Amol
City
Amol
Postal code
Phone
+98 12 1222 1919
Fax
+98 12 1215 1220
Email
roghiehnazari@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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