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The Impact of foot massage on anxiety before and after hysterectomy

Protocol summary

Summary
1 -The main goal: The effect of foot massage on anxiety before and after hysterectomy 2 - Study design: The clinical study, 2 groups (intervention and control) the randomly selected 3 - Interventions: The intervention ( massage) once a day, 20 minute foot massage is done that started one day before surgery to 2 days after surgery to continue. In the control group patients in parallel with a time massage intervention group, research on the bedside will be present in the two groups before and 30 minutes after the massage Questionnaire Anxiety addition, Berger by researcher will be completed as well as vital signs, including: pulse, respiration and bp is measured and recorded. 4 - Main Outcomes: Outcomes are measurable anxiety and vital sign. Inclusion Criteria: At least literate; not having the surgery except oophorectomy; hysterectomy to benign compliant until study time; No history of foot massage; After gaining consciousness; At least one day before surgery and 2 days after surgery in the hospital; For long term (more than one month), tranquilizers, pain or anxiety drugs such as inderal is not received; Lack of drug addiction; No known diseases as diabetes, heart disease, mental disorders, movement disorders, impaired vision, hearing; having a healthy part of legs Exclusion criteria: Severe complications after surgery, such as bleeding, infection, need for care in the intensive care unit; Lack of access to experimental conditions during the study (compliant and discomfort and ...); Lack of patient consent to continue participation in the study

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201301196284N5
Registration date: 2013-05-18, 1392/02/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-18, 1392/02/28
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2013-01-24, 1391/11/05
Expected recruitment end date
2013-05-31, 1392/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of foot massage on anxiety before and after hysterectomy
Public title
Effect of foot massage on anxiety before and after hysterectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: At least literate; not having the surgery With the exception of oophorectomy; hysterectomy to benign compliant until time study; No having history of foot massage; After gaining consciousness; At least one day before surgery and 2 days after surgery in the hospital; For long term (more than one month, tranquilizers, pain or anxiety drugs such as inderal is not received; Lack of drug addiction; No known diseases as diabetes, heart disease, mental disorders, movement disorders, impaired vision, hearing; having a healthy part of legs. Exclusion criteria: Severe complications after surgery such as bleeding, infection, need for care in the intensive care unit; Lack of access to experimental conditions during the study (for example discomfort and ...); Lack of patient consent to continue participation in the study.
Age
From 20 years old to 85 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Tehran university of Medical sciences
Street address
sixth floor,centeral organization of university, edge of Qods street, keshavarz blvd, Tehran
City
Tehran
Postal code
Approval date
2012-07-11, 1391/04/21
Ethics committee reference number
668 /130/د/91

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
f40-f41-f4
ICD-10 code description
Neurotic, stress-related and somatoform disorders

Primary outcomes

1

Description
Anxiety
Timepoint
Before and 30 minutes after the first intervention, before and 30 minutes after the second intervention, before and 30 minutes after the third intervention, one week after hysterectomy
Method of measurement
Anxiety by STAI anxiety questionnaire measures .

2

Description
Vital sign
Timepoint
Before and 30 minutes after the first intervention, before and 30 minutes after the second intervention, before and 30 minutes after the third intervention
Method of measurement
vital signs, including blood pressure through mercury sphygmomanometer in millimeters of mercury and pulse through touch radial arterial of hand for 1 minute and respiratory through movement chest for 1 minute.

Secondary outcomes

1

Description
Age patient
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

2

Description
Patient job
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

3

Description
Patient husband job
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

4

Description
Income
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

5

Description
Patient education
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

6

Description
Patient husband education
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

7

Description
Marital status
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

8

Description
Number of children
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

9

Description
Menopause status
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

10

Description
Anesthesia method
Timepoint
Before second intervention
Method of measurement
Operation questionaire

11

Description
Surgery method
Timepoint
Before second intervention
Method of measurement
Operation questionaire

12

Description
Hysterectomy reason
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

13

Description
Duration of disease diagnosis
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

14

Description
Surgery history
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

15

Description
Hospitalization
Timepoint
Before first intervention
Method of measurement
Demographic information questionaire

16

Description
The amount of medication to reduce pain
Timepoint
First and second day after surgery
Method of measurement
Recorded in milligrams per questionnaire Surgery

Intervention groups

1

Description
In control group patients during the massage in intervention group, attended the bedside for 20 minutes and create rapport addition, Berger anxiety questionnaire before and 30 minutes after the intervention is completed. One week after surgery for following again berger state questionaire with patient by the researcher calling is completed.
Category
Other

2

Description
In patient intervention group foot special massage done. In this massage base of the palm,the palm and fingers to movement rubbing, rotation, pull, grasping, push and flexing in different part ( both sides of foots, the narrow foot, toe, heel, edge toe, fingers, between fingers, the dorsal surface of the foot, the inner edge of edge of the foot, the up surface of the foot) used. The general movement of the ankle and toes done . The massage is a 3 step, 20 movement in each specialized massage movement are carried out on the patient legs. This massage during 20 minutes done (each foot 10 minutes). This intervention one day before surgery and first, second postoperative day is performed on patients once a day in the intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariate and Valeasr hospitals of Tehran
Full name of responsible person
Zohre Maryami
Street address
faculty of nursing and midwifery, beginning of the Nosrat street,Tohid square, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotuhi
Street address
sixth floor,centeral organization of university, edge of Qods street,keshavarz blvd,Tehran
City
Tehran
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 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
Nursing-Midwifery university
Full name of responsible person
Maryam Modarres
Position
Phd student in Medical education
Other areas of specialty/work
Street address
faculty of nursing and midwifery, beginning of the Nosrat street,Tohid square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
ma_modars@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing-Midwifery university
Full name of responsible person
Maryam Modarres
Position
Phd student in Medical education
Other areas of specialty/work
Street address
faculty of nursing and midwifery, beginning of the Nosrat street,Tohid square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
ma_modars@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing-Midwifery University
Full name of responsible person
Zohre Maryami
Position
Master student of Midwifery
Other areas of specialty/work
Street address
faculty of nursing and midwifery, beginning of the Nosrat street,Tohid square, Tehran
City
Tehran
Postal code
Phone
+98 51 1724 9272
Fax
Email
zohre.maryami@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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