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Protocol summary
A clinical trial with a control group, simple randomization, with parallel, and hospital-based. The samples include 90 elderly women undergoing knee replacement surgery. There is no trial phase.
A clinical trial with a control group, simple randomization, with parallel, and hospital-based. The samples include 141elderly women undergoing knee replacement surgery. There is no trial phase.
A clinical trial with a control group, simple randomization, with parallel, and hospital-based. The samples include 90 elderly141elderly women undergoing knee replacement surgery. There is no trial phase.
کارآزمایی بالینی دارای گروه کنترل، تصادفیسازی ساده، با گروه های موازی و مبتنی بر بیمارستان است. حجم نمونه 90 سالمند زن تحت جراحی تعویض مفصل زانو،
فاز کارآزمایی مصداق ندارد.
کارآزمایی بالینی دارای گروه کنترل، تصادفیسازی ساده، با گروه های موازی و مبتنی بر بیمارستان است. حجم نمونه 141 سالمند زن تحت جراحی تعویض مفصل زانو،
فاز کارآزمایی مصداق ندارد.
کارآزمایی بالینی دارای گروه کنترل، تصادفیسازی ساده، با گروه های موازی و مبتنی بر بیمارستان است. حجم نمونه 90141 سالمند زن تحت جراحی تعویض مفصل زانو، فاز کارآزمایی مصداق ندارد.
General information
90
141
90141
empty
Increasing the sample size from 30 to 47 with the approval of the Ethics Committee of Shahed University
Increasing the sample size from 30 to 47 with the approval of the Ethics Committee of Shahed University
empty
افزایش حجم نمونه از 30 به 47 با تصویب کمیته اخلاق دانشگاه شاهد
افزایش حجم نمونه از 30 به 47 با تصویب کمیته اخلاق دانشگاه شاهد
Ninety cards (equal to the number of sample volumes) will be prepared. Then A, B, or C will be written on each card (30 cards A, 30 cards B, and 30 cards C). These cards will be placed inside an opaque box so that no one can see the cards inside the box. In this way, three cards are prepared and one of the words A (acupressure), B (auriculotherapy), and C (control) will be written on each card. After shuffling the cards by the researcher, patients are asked to randomly take a card from the box (selected cards will not be returned to the box after selection). This process will continue until the sample size is completed
Hundred & one cards (equal to the number of sample volumes) will be prepared. Then A, B, or C will be written on each card (47 cards A, 47 cards B, and 47 cards C). These cards will be placed inside an opaque box so that no one can see the cards inside the box. In this way, three cards are prepared and one of the words A (acupressure), B (auriculotherapy), and C (control) will be written on each card. After shuffling the cards by the researcher, patients are asked to randomly take a card from the box (selected cards will not be returned to the box after selection). This process will continue until the sample size is completed
NinetyHundred & one cards (equal to the number of sample volumes) will be prepared. Then A, B, or C will be written on each card (3047 cards A, 3047 cards B, and 3047 cards C). These cards will be placed inside an opaque box so that no one can see the cards inside the box. In this way, three cards are prepared and one of the words A (acupressure), B (auriculotherapy), and C (control) will be written on each card. After shuffling the cards by the researcher, patients are asked to randomly take a card from the box (selected cards will not be returned to the box after selection). This process will continue until the sample size is completed
در یک جعبه مات 90 کارت که بر روی 30 کارت حرف A و 30 کارت حرف B و 30 کارت حرف C نوشته شده باشد قرار داده می شود. بطوری که دیدن کارت های داخل جعبه برای هیچ کس امکان پذیر نباشد. پس از هم زدن کارت ها توسط محقق، از بیماران درخواست می شود که به صورت اتفاقی یک کارت از داخل جعبه بردارند. در صورتی که کارت A بردارند در گروه مداخله طب فشاری بدن، کارت B در گروه مداخله طب فشاری گوش و در صورتی که کارت C بردارند در گروه کنترل قرارخواهند گرفت (کارت های برگزیده پس از انتخاب به داخل جعبه باز نمی گردند). این روند تا تکمیل حجم نمونه مد نظر ادامه می یابد.
در یک جعبه مات 141 کارت که بر روی 47 کارت حرف A و 47 کارت حرف B و 47 کارت حرف C نوشته شده باشد قرار داده می شود. بطوری که دیدن کارت های داخل جعبه برای هیچ کس امکان پذیر نباشد. پس از هم زدن کارت ها توسط محقق، از بیماران درخواست می شود که به صورت اتفاقی یک کارت از داخل جعبه بردارند. در صورتی که کارت A بردارند در گروه مداخله طب فشاری بدن، کارت B در گروه مداخله طب فشاری گوش و در صورتی که کارت C بردارند در گروه کنترل قرارخواهند گرفت (کارت های برگزیده پس از انتخاب به داخل جعبه باز نمی گردند). این روند تا تکمیل حجم نمونه مد نظر ادامه می یابد.
در یک جعبه مات 90141 کارت که بر روی 3047 کارت حرف A و 3047 کارت حرف B و 3047 کارت حرف C نوشته شده باشد قرار داده می شود. بطوری که دیدن کارت های داخل جعبه برای هیچ کس امکان پذیر نباشد. پس از هم زدن کارت ها توسط محقق، از بیماران درخواست می شود که به صورت اتفاقی یک کارت از داخل جعبه بردارند. در صورتی که کارت A بردارند در گروه مداخله طب فشاری بدن، کارت B در گروه مداخله طب فشاری گوش و در صورتی که کارت C بردارند در گروه کنترل قرارخواهند گرفت (کارت های برگزیده پس از انتخاب به داخل جعبه باز نمی گردند). این روند تا تکمیل حجم نمونه مد نظر ادامه می یابد.
Protocol summary
Study aim
Determining and comparing the effect of auricular acupressure and Body acupressure on pain and anxiety in female older adults undergoing knee replacement arthroplasty
Design
A clinical trial with a control group, simple randomization, with parallel, and hospital-based. The samples include 141elderly women undergoing knee replacement surgery. There is no trial phase.
Settings and conduct
Patients undergoing Knee Replacement Arthroplasty in Shafa Yahyaian Hospital in Tehran city are divided into three groups: acupressure, auriculotherapy, and control. After surgery, the amount of pain and anxiety are measured, then the intervention is performed. The pain and anxiety will be assessed end of the first day, after the last intervention on the second day, and after the last intervention on the third day. The researcher assistant who is unaware of the groupings and type of interventions in each group .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 60 years and over, Absence of cognitive impairment, Ability to communicate, Non-alcohol and drug addiction, lack of experience or simultaneous participation in similar training sessions, Lake of history of mental illness, the first experience with knee replacement arthroplasty, Undergoing spinal anesthesia, Lake of malignancy, the lake of inflammatory disease, and vascular disease, Having no active bleeding, sensory disorders, pain, infectious wounds, and skin disease at the intervention site.
Exclusion criteria: Unwillingness to cooperate with a patient or physician, Return to the operating room.
Intervention groups
The first Intervention group: patients received auricular acupressure. The second Intervention group: patients who received body acupressure.
Main outcome variables
Pain, Anxiety
General information
Reason for update
Increasing the sample size from 30 to 47 with the approval of the Ethics Committee of Shahed University
Acronym
IRCT registration information
IRCT registration number:IRCT20110912007529N28
Registration date:2023-07-10, 1402/04/19
Registration timing:prospective
Last update:2024-02-12, 1402/11/23
Update count:1
Registration date
2023-07-10, 1402/04/19
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-05-18, 1403/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of auricular acupressure and body acupressure on pain and anxiety in older adults undergoing knee replacement arthroplasty
Public title
Comparing the effect of auricular acupressure and body acupressure on pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years and over
Absence of cognitive impairment
Ability to communicate
Non-alcohol and drug addiction
Lack of experience or simultaneous participation in similar training sessions
Lake of history of mental illness
The first experience with knee replacement arthroplasty
Undergoing spinal anesthesia
Lake of malignancy, lake of inflammatory disease, and vascular disease
Having no active bleeding, sensory disorders, pain, infectious wounds and skin disease at the intervention site
Exclusion criteria:
Unwillingness to co-operate with a patient or physician
Return to the operating room
Age
From 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
141
Randomization (investigator's opinion)
Randomized
Randomization description
Hundred & one cards (equal to the number of sample volumes) will be prepared. Then A, B, or C will be written on each card (47 cards A, 47 cards B, and 47 cards C). These cards will be placed inside an opaque box so that no one can see the cards inside the box. In this way, three cards are prepared and one of the words A (acupressure), B (auriculotherapy), and C (control) will be written on each card. After shuffling the cards by the researcher, patients are asked to randomly take a card from the box (selected cards will not be returned to the box after selection). This process will continue until the sample size is completed
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 Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran. Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2023-06-19, 1402/03/29
Ethics committee reference number
Shahed.REC.1402.024
Health conditions studied
1
Description of health condition studied
Knee joint replacement
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day.
Method of measurement
Visual Pain Scale
2
Description
Quality of pain
Timepoint
Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day.
Method of measurement
MacGill questionnaire
3
Description
Intensity of anxiety
Timepoint
Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day.
Method of measurement
Visual Analogue Scale Anxiety) VASA)
4
Description
Quality of anxiety
Timepoint
Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day.
Method of measurement
The Spielberger Inventory
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day.
Method of measurement
Digital arm l sphygmomanometer
2
Description
Pulse rate
Timepoint
Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day.
Method of measurement
Enumeration of pulse rate
3
Description
Respiration rate
Timepoint
Before the first intervention on the first day, after the last intervention on the first day, after the last intervention on the second day, and after the last intervention end on the third day.
Method of measurement
Enumeration of Respiration rate
Intervention groups
1
Description
Intervention group: interventional therapy ear acupuncture At first, disinfection of both outer auricles using 70% alcohol, and then during 3 days, every day three times, each time for each point 3 minutes medium equitability on glue ear (ear plaster containing seed) on a three-point on the auricle, Shen Men, knee, Thalamus given
Category
Other
2
Description
Intervention group: interventional therapy body acupuncture including: At first, during 3 days, every day three times, each time for each point 3 minutes (on a three-point on the Hegu LI4 (LargIntestine4), LI10(Shousanli) and Yintang).
Category
Other
3
Description
Control group: This group is provided by routine care.
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 3071
Fax
Email
bijani@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2100
Fax
Email
nrejeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 000
Email
nrejeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2100
Email
nrejeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information about the original outcome after being unidentifiable is shared.
When the data will become available and for how long
The access period is up to after the publication of the results.
To whom data/document is available
Results is available to academic researchers
Under which criteria data/document could be used
A new analysis of the data can only be done by explaining the reasons for the request for such an analysis and with the knowledge of the researcher.
From where data/document is obtainable
They can correspond with the person responsible for this clinical trial(Nahid Rejeh) to receive the data (nrejeh@yahoo.com.)
What processes are involved for a request to access data/document
After receiving the application for having a data file and obtaining permission from the university vice-chancellor, the data file after the publication of the results is shared