Determining the effect of acupressure on pain and sleep quality of cancer patients after surgery in the intensive care unit
Design
A clinical trial with a control group with parallel groups, single blind, on 80 patients who will be assigned to two groups of experimental and control by blocking method with size 4.
Settings and conduct
This study will be performed in the intensive care unit of the Cancer Institute of Imam Khomeini Hospital Complex and patients who meet the inclusion criteria will be included in the study. This is a single blind study so that patients, will be unaware of receiving original or similar acupressure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at least 18 years old, being diagnosed with any type of cancer, pain related to cancer surgery and pain expressed by the patient, having full consciousness, ability to listen and speak, and having a minimum ability to read and write
Exclusion criteria: cognitive and behavioral disorders (self-manifestation), mental disorder to the extent of daily use of psychiatric drugs, and history of amputation, surgery, or wound in pressure points
Intervention groups
Intervention group: On the second and third day after surgery, patients with cancer who suffers severe pain, are exposed to massage on the LI4 and SP6 points with 10 seconds of pressure, 2 seconds of rest for 8 minutes in the morning and evening. Control group: On the second and third day after surgery, patients with cancer who suffers severe pain are exposed to the superficial touch of LI4 and SP6 points for 10 seconds of pressure, 2 seconds of rest for 8 minutes in the morning and evening.
Main outcome variables
Pain and sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220111053686N1
Registration date:2022-05-29, 1401/03/08
Registration timing:prospective
Last update:2022-05-29, 1401/03/08
Update count:0
Registration date
2022-05-29, 1401/03/08
Registrant information
Name
Mahya Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7726 3242
Email address
m-jafari@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-31, 1401/03/10
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on pain and sleep quality of cancer patients undergoing surgery admitted to the intensive care unit
Public title
The effect of acupressure on pain and sleep quality in cancer patients after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Be at least 18 years old
Diagnosis of any type of cancer
Having chronic pain in connection with cancer surgery and its expression by the patient
Having full consciousness
Listening and speaking ability
Minimum ability to read and write
Exclusion criteria:
cognitive and behavioral disorders
mental disorder to the extent of daily use of psychiatric drugs
history of limb amputation, surgery or wound in pressure points
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used to allocate samples (block size: 4). Thus, the letter A is considered for the intervention group and the letter B for the control group. Then all the permutation combinations of the letters A, A, B and B, which are 6 different combinations, are written on the 6 cards in the following order:AABB،ABBA،ABAB،BAAB،BABA،BBAA.Then, from numbers 1 to 6, a card will be randomly selected by patient number one.For example, number 2 was chosen, which means that the first person in the intervention group, the next two people in the control group and the fourth person in the intervention group, and this process continued until the sample size reached the quorum.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is a single blind study in which patients are unaware that they are receiving acupressure or gentle surface pressure. The intervention group will receive acupressure and the control group will receive a gentle surface pressure at the same points.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Ethics Committee of Shahid Rajaei Cardiovascular Center
Street address
2nd floor, research building, Shahid Rajaei Research & Training Hospital, Next to Mellat Park, Vali-Asr Ave, Tehran, IRAN
City
tehran
Province
Tehran
Postal code
1995614331
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.RHC.REC.1400.121
Health conditions studied
1
Description of health condition studied
other acute post procedural pain
ICD-10 code
G89.18
ICD-10 code description
Other acute post procedural pain
Primary outcomes
1
Description
Percentage of people with a pain score of 7 or more
Timepoint
Twice a day on the second and third days after surgery
Method of measurement
Visual Analogue Scale
2
Description
sleep quality
Timepoint
Before the intervention and in the morning after the last intervention
Method of measurement
The Richards-Campbell Sleep Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 40 patients with cancer admitted to the intensive care unit who suffer severe pain after surgery (pain score of 7 or more based on the Pain Visual Analog Scale), on the second and third day after surgery will be exposed to acupressure massage, on the LI4 points (between the base of thumb and index finger) and the SP6 points (the shin bone on the inside of the ankle) for periods of 10 seconds of pressure and 2 seconds of rest for 8 minutes in the morning and evening.
Category
Rehabilitation
2
Description
Control group: 40 cancer patients admitted to the intensive care unit who suffer severe pain after surgery (pain score of 7 or more based on the Pain Vision Analog Scale), on the second and third days after surgery will be exposed to superficial touch on LI4 points and SP6 during periods of 10 seconds of pressure and 2 seconds of rest for 8 minutes in the morning and evening.
Shahid Rajaei Cardiovascular Research and Training Center
Full name of responsible person
Dr Fidan Shabani
Street address
2nd floor, research building, Shahid Rajaei Research & Training Hospital, Next to Mellat Park, Vali-Asr Ave, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2287
Fax
+98 21 2204 2026
Email
fidannahal@yahoo.com
Web page address
http://internatinal-unit.rhc.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajaei Cardiovascular Research and Training Center
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
Iran University of Medical Sciences
Full name of responsible person
Mahya Jafari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, No. 12, Jahangiri Alley, Mahmoudi St, South Madani St
City
Tehran
Province
Tehran
Postal code
1643673174
Phone
+98 21 7726 3242
Fax
Email
m-jafari@alumnus.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahya Jafari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, No. 12, Jahangiri Alley, Mahmoudi St, South Madani St
City
Tehran
Province
Tehran
Postal code
1643673174
Phone
+98 21 7726 3242
Fax
Email
m-jafari@alumnus.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahya Jafari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 1, No. 12, Jahangiri Alley, Mahmoudi St, South Madani St
City
Tehran
Province
Tehran
Postal code
1643673174
Phone
+98 21 7726 3242
Fax
Email
m-jafari@alumnus.tums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on age, sex, type of cancer, marital status, occupation, education, place of residence, history of smoking, drug and alcohol use, and receiving painkillers on the second and third days after surgery can be shared.
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
All academics and researchers and professionals in the field of treatment
Under which criteria data/document could be used
.In order to conduct more and more comprehensive research and complete the research process for its clinical application..
From where data/document is obtainable
mahya jafari
jafari.mh1990@gmail.com
What processes are involved for a request to access data/document
After sending an email to the researcher, the file and documents will be provided to the people in a short time.