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The Effect of Foot Reflexology Massage on Pain, Anxiety & Physiological parameters in Patients Undergoing Tibia Plaque Surgery

Protocol summary

Study aim
The Effect of Foot Reflexology Massage on Pain, Anxiety & Physiological parameters in Patients Undergoing Tibia Plaque Surgery In Imam Ali (AS) Educational Hospital in Bojnourd in 2020
Design
Clinical trial with control group, with parallel, two-way blind groups, randomized on 96 patients. Block randomized randomized method was used for randomization.
Settings and conduct
This study is performed in Imam Ali Hospital in Bojnourd to evaluate the effectiveness of foot reflex massage on pain, anxiety and physiological indicators of patients under tibial plaque surgery. In this study, 96 patients were randomly assigned to two groups of intervention and control. The test group receives the intervention for 10 minutes and about 2 hours before surgery. The variables studied are measured at specific intervals. None of the patients participating in the study, as well as the person evaluating the outcome and the person analyzing the data, are aware of the study groups.
Participants/Inclusion and exclusion criteria
Entry requirements: Having a healthy limb in the area of ​​the healthy sole of the foot and toes,At least 3 hours have passed since receiving the last analgesic, Absence of fractures in other areas of the patient's body, receiving general anesthesia and patient satisfaction. Conditions of non-entry: Suffering from motor sensory disorders, Vascular diseases,Inflammation and diabetes, history of massage, drug and alcohol addiction, chronic pain such as migraine, history of anti-anxiety drugs, patient dissatisfaction
Intervention groups
There are two groups in this study. The test group receives the intervention as a reflex massage of the sole of the foot for 10 minutes. The massage control group does not receive.
Main outcome variables
Postoperative pain؛ Anxiety؛ Physiological indicators (systolic blood pressure, diastolic blood pressure and heart rate)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200502047265N1
Registration date: 2020-06-30, 1399/04/10
Registration timing: retrospective

Last update: 2020-06-30, 1399/04/10
Update count: 0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Fateme Imani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3224 6834
Email address
fateme.imany@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-29, 1399/02/10
Expected recruitment end date
2020-06-30, 1399/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology Massage on Pain, Anxiety & Physiological parameters in Patients Undergoing Tibia Plaque Surgery
Public title
The Effect of Foot Reflexology Massage on Pain, Anxiety & Physiological parameters in Patients Undergoing Tibia Plaque Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a healthy limb in a healthy sole of the foot and toes Spend at least 3 hours receiving the last analgesic No fractures in other areas of the patient's body Get general anesthesia Patient satisfaction
Exclusion criteria:
Sensory motor disorders Having vascular disease History of massage Suffering from inflammatory diseases and diabetes Drug and alcohol addiction Chronic pain such as migraines History of anti-anxiety drugs Dissatisfaction of patients
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
96 Patients referred to Imam Ali Hospital (AS) who are candidates forTibial Plaque surgery and other criteria for entering the study, They will be selected as available samples. They will then be randomly assigned to two groups of 48 test and control. Patient allocation in two intervention groups and control group using the method randomly blocked four AACC blocks will be. 24 Blocks were randomly selected and the patients' entry numbers were determined sequentially and placed on the envelope. The type of intervention is done inside the envelope and when the type of intervention is referred. (The letter A indicates the test person and the C letter indicates the control person)
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants who entered the study with satisfaction do not know which group they belong to. The outcome assessor also does not know which group the patient belongs to. Only the intervener knows the groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences.Vali-e-Asr Highway,Three ways Joybar,Imam Khomeini Square.
City
Sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MAZUMS.REC.1399.110

Health conditions studied

1

Description of health condition studied
Fracture of the tibia, which requires plaque surgery.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain score Based on scale (VAS)
Timepoint
Beginning of study; 1 hour after the intervention and in the hours of 2, 4, 6, 12 and 24 hours after the surgery
Method of measurement
Visual Analog Scale(VAS).

Secondary outcomes

1

Description
Anxiety score based on Spiel Berger's questionnaire
Timepoint
At the beginning of the study and 24 hours after surgery
Method of measurement
Spiel Berger's Anxiety Questionnaire

Intervention groups

1

Description
Intervention group: In this group using baby oil that has no therapeutic value For ten minutes, reflexive foot massage is performed on patients' healthy feet
Category
Treatment - Other

2

Description
Control group: The researcher lubricates the healthy foot for a minute without any pressure, using baby oil that has no therapeutic value, to eliminate the effect of touch alone. The researcher stayed with the patient for a total of 10 minutes so that the effect of the presence of the massager was equal for both groups.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital in Bojnourd
Full name of responsible person
fateme Imani
Street address
Shahriar Street, Imam Ali Hospital.
City
Bojnourd
Province
North Khorasan
Postal code
9417787885
Phone
+98 58 3274 6834
Email
fateme.imany@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Central Headquarters of Mazandaran University of Medical Sciences, Vali Asr Highway, Seh Rah Joybar, Imam Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
publicrel@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Imani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 17, Yasin 6 Street, Shargh Sepah,
City
Bojnourd
Province
North Khorasan
Postal code
9417787885
Phone
+98 58 3274 6834
Email
fateme.imany@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Imani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 17, Yasin 6 Street, shargh sepah.
City
Bojnourd
Province
North Khorasan
Postal code
9417787885
Phone
+98 58 3274 6834
Email
fateme.imany@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Imani
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 17,Yasin 6 St, shargh sepah.
City
Bojnourd
Province
North Khorasan
Postal code
9417787885
Phone
+98 58 3274 6834
Email
fateme.imany@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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