Protocol summary

Summary
The present study aims to compare the effects of hand and foot reflexology massages on stress and anxiety in candidate patients undergoing upper gastrointestinal endoscopy.The research community consisted of all endoscopy candidate patients who refer to 22 Bahman Hospital Polyclinic of Neyshabour city.They are 95 person (in three groups of hand reflexology,foot reflexology and control). In the present study, the initial sampling will be conducted randomly.In the intervention groups, reflexology massage for 20 minutes before endoscopic procedures done And the control group receiving usual care.reflexology massages will performed for the head, pituitary gland, diaphragm, lung and kidney / adrenal in the experimental groups.Then the patients stress and anxiety will measured using depression, anxiety and stress Scale.(DASS-21)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070828837N1
Registration date: 2016-12-24, 1395/10/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-24, 1395/10/04
Registrant information
Name
Shima Shaermoghadam
Name of organization / entity
Zabol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 3948
Email address
sh.shaermoghaddam@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Zabol University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Foot and Hand Reflexology Massages on Stress and Anxiety in Candidate Patients Undergoing esophagogastroduodonoscopy
Public title
Comparison of the Effects of Foot and Hand Reflexology Massages on Stress and Anxiety in Candidate Patients Undergoing Upper Gastrointestinal Endoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : a prescription for upper gastrointestinalendoscopy, aged from 18 to 60, capability to speak and understand Persian, no sign of deafness and vision impairment, no history of endoscopy, no prescription for emergency endoscopy, no history of mental illness, not using opium, no intake of tranquilizers, Iranian nationality,no history of neuropathy diseases such as diabetes and myasthenia gravis. Exclusion criteria : a history of psychological problems or known anxiety disorders, using hypnotics and tranquilizers, drug addiction or addiction to strong painkillers, no willingness to cooperate in the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 95
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization by table of random numbers

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of zabol University of Medical Sciences
Street address
zabol University of Medical Sciences
City
Zabol
Postal code
‌9861663335
Approval date
2016-03-09, 1394/12/19
Ethics committee reference number
zbmu.I.REC.1394.134

Health conditions studied

1

Description of health condition studied
digestive diseases
ICD-10 code
XI
ICD-10 code description
Diseases of the digestive system

Primary outcomes

1

Description
stress after the hand and foot reflexology massage
Timepoint
before intervention,after intervention,Immediately before the endoscopy
Method of measurement
DASS-21

2

Description
anxiety after the hand and foot reflexology massage
Timepoint
before intervention,after intervention,Immediately before the endoscopy
Method of measurement
DASS-21

Secondary outcomes

empty

Intervention groups

1

Description
hand reflexology
Category
Treatment - Other

2

Description
no intervention in control group
Category
Other

3

Description
foot reflexology
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nishapur Hospital Polyclinic
Full name of responsible person
Tooba Hoseinabadi
Street address
22 Bahman Hospital
City
Nishapur

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Zabol University of Medical Sciences
Full name of responsible person
Mohammadreza Firoozkoohi
Street address
Zabol University of Medical Science
City
Zabol
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 Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Shima Shaermoghadam
Position
Nursing Masters Student
Other areas of specialty/work
Street address
22 Bahman Hospital
City
Nishabur
Postal code
9317883111
Phone
+98 51 4333 5372
Fax
Email
shima6814@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Hosein Shahdadi
Position
Master of nursing
Other areas of specialty/work
Street address
Zabol University of Medical Sciences
City
Zabol
Postal code
Phone
+98 54332235737
Fax
Email
zb5950@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zabol university of medical sciences
Full name of responsible person
Shima Shaermoghadam
Position
nursing Masters student
Other areas of specialty/work
Street address
22 Bahman Hospital
City
nishabur
Postal code
9317883111
Phone
+98 51 4333 5372
Fax
Email
shima6814@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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