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Assessing the Effect of Foot Reflexology Massage on Anxiety Level and Physiological Indexes in Bronchoscopies candidates

Protocol summary

Summary
The aim of this study is to determine the effects of foot reflexology massage on anxiety level and physiological indexes among pulmonary patients admitted and candidate for bronchoscopy. Inclusion criteria are: age of 18 to 60, being conscious, having no previous bronchoscopy, having no problem on feet, having no bleeding and vision disorder. Exclusion criteria are: cancellation of bronchoscopy and patient’s withdrawal. In this single-blind clinical trial, 70 bronchoscopy candidate patients are divided into two groups, experimental (35individuals ) and control (35 individuals) by assigning a random coin toss between two patients. Researcher one day before the procedure is presented at patient’s bedside, and after obtaining informed consent, demographic data questionnaire will have completed by questioner and then patients are given one of experimental or control groups. Physiological indexes (blood pressure, heart rate, respiration rate and arterial oxygen saturation) and anxiety of the subjects, are measured by the second researcher that is unaware of samples in each group in three stages: The first time morning bronchoscopy before the intervention, immediately after the intervention and immediately before bronchoscopy. Foot reflexology intervention is done for each leg about 15 minutes (5 minute warm up, 10 minute massage pressure points), In the experimental group on foot reflexology points on the solar plexus, pituitary, heart and lung . Control group dose not receive any intervention. The main outcome variables are anxiety and physiological indexes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014091319141N1
Registration date: 2015-01-12, 1393/10/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-01-12, 1393/10/22
Registrant information
Name
Hooman Shahsavari
Name of organization / entity
The faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4319
Email address
h_shahsavari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Siences
Expected recruitment start date
2014-10-07, 1393/07/15
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Effect of Foot Reflexology Massage on Anxiety Level and Physiological Indexes in Bronchoscopies candidates
Public title
Assessing the Effect of Foot Reflexology Massage on Anxiety Level and Physiological Indexes(Blood pressure, Heart rate, Respiration rate, Arterial oxygen saturation) in Bronchoscopies candidates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: written consent for participation in the study; age of 18 to 60; ability to speak and comprehend Persian; being conscious; having no problem on feet; no previous record for bronchoscopy or participation in similar research; no prescription for mandatory urgent bronchoscopy; no previous record on psychological or anxiety disorders (according to the patient’s self-report or medical history); no pain; no addiction to drug, alcohol, or strong sedatives; no vision impairment that prevents selecting proper choices on visual analog scale for assessing anxiety level; no bleeding disorder. Exclusion criteria: cancellation of bronchoscopy procedure on the scheduled day; and patient’s withdrawal.
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: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
The Central Building of Tehran University of Medical Scienc, keshavarz Street, Qods Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-09-28, 1393/07/06
Ethics committee reference number
130/1629

Health conditions studied

1

Description of health condition studied
Bronchoscopy(diagnostic prosedure)
ICD-10 code
Z03
ICD-10 code description
Medical observation and evaluation for suspected diseases and conditions

Primary outcomes

1

Description
Anxiety
Timepoint
in the morning of the day of bronchoscopy prior to the intervention, immediately after the intervention, and immediately before bronchoscopy (after the intervention)
Method of measurement
Visual Analog Scale questionnaire

2

Description
Heart rate
Timepoint
in the morning of the day of bronchoscopy prior to the intervention, immediately after the intervention, and immediately before bronchoscopy (after the intervention)
Method of measurement
Radial puls count through touch

3

Description
Respiration rate
Timepoint
in the morning of the day of bronchoscopy prior to the intervention, immediately after the intervention, and immediately before bronchoscopy (after the intervention)
Method of measurement
Enumeration

4

Description
Arterial Oxygen Saturation
Timepoint
in the morning of the day of bronchoscopy prior to the intervention, immediately after the intervention, and immediately before bronchoscopy (after the intervention)
Method of measurement
Vital signs monitoring device

5

Description
Blood pressure
Timepoint
in the morning of the day of bronchoscopy prior to the intervention, immediately after the intervention, and immediately before bronchoscopy (after the intervention)
Method of measurement
Vital signs monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
foot reflexology massage for 30 minutes on pituitary reflex points, solar plexus, heart, and lungs on the day of bronchoscopy and prior to the bronchoscopy procedure
Category
Other

2

Description
routine care for the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Shariati Hospital
Full name of responsible person
Marzieh Ebrahimi Eshrat Abad
Street address
Dr Shariati Hospital,North Kargar street,Tehran,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Younesian
Street address
The central building of Tehran University of Medical Sciences, Qods Street, Keshavarz Street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
The faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Full name of responsible person
Marzieh Ebrahimi Eshrat Abad
Position
Master Sciences Student of Nursing
Other areas of specialty/work
Street address
The faculty of Nursing and Midwifery of Tehran University of Medical Sciences, Nosrat Street, Towhid Squre, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6692 9062
Fax
Email
mebrahimi1981@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
The faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Full name of responsible person
Hooman Shahsavari
Position
PHD
Other areas of specialty/work
Street address
The faculty of Nursing and Midwifery of Tehran University of Medical Sciences, Nosrat Street, Towhid Squre, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6105 4342
Fax
+98 21 6690 4252
Email
h_shahsavari@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Full name of responsible person
Marzieh Ebrahimi Eshrat Abad
Position
Master Sciences Student of Nursing
Other areas of specialty/work
Street address
The faculty of Nursing and Midwifery of Tehran University of Medical Scienses, Nosrat Street, Towhid Squre
City
Tehran
Postal code
Phone
+98 21 6692 9062
Fax
Email
mebrahimi1981@yahoo.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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