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The Effect of Cold and Vibration Maneuver on Cancer Patients' Satisfaction and their Pain Relief during Cannulation Insertion: A Randomized Controlled Trial

Protocol summary

Study aim
1. To assess the pain and satisfaction for the patient with cancer during cannulation for control group. 2.To determine the effect of application three intervention groups on the level of pain and satisfaction during cannula insertion. 5. To compare effect of application of maneuvers on patients with cancer during cannulation
Design
A factorial, Randomized control trial design , to determine the effect of the three intervention groups and one control group on pain and satisfaction for patients with cancer during cannulation. Sample size is 223.
Settings and conduct
Oncology center in Al- Habobi teaching hospital in Thi-Qar Nasseryia city, Iraq. Single blind in this trial, the participant is kept blinded to their group assignment (interventions and control groups) throughout the study.
Participants/Inclusion and exclusion criteria
Inclusion: consent & compliance with all aspects of the clinical trial, methods, providing data during follow-up phase. Contact male & female patients with cancer, who are 18-70 years old at the time of the data collection phase. Exclusion: Involvement with any other ongoing studies. Medically diagnosed with psycho-mental diseases.
Intervention groups
Firstly, a tourniquet was applied on the wrist and the type of three intervention groups (ice wing only, vibration only, and both ice wing and vibration) all intervention fixed with other tourniquet or tape and was placed about(3-5cm) to the site of cannula insertion. All intervention in experiments applied (30-60) seconds before insert the cannula. after success cannula inserted at first attempt the Visual Analogue Scale (VAS) was measured pain intensity and satisfaction when patient mentioned a point on the VAS line that represent the perception of pain, satisfaction, pain and satisfaction assess separately.
Main outcome variables
Minimizing or relief the cannulation pain during insertion. Satisfying of patient with procedures.

General information

Reason for update
Acronym
A Randomized controlled trial (ARCT)
IRCT registration information
IRCT registration number: IRCT20230310057672N3
Registration date: 2024-04-01, 1403/01/13
Registration timing: registered_while_recruiting

Last update: 2024-04-01, 1403/01/13
Update count: 0
Registration date
2024-04-01, 1403/01/13
Registrant information
Name
Alaa Jawad
Name of organization / entity
University of Baghdad/College of Nursing
Country
Iraq
Phone
+964 1 521 1494
Email address
alaaj@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-01, 1403/01/13
Expected recruitment end date
2024-05-05, 1403/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cold and Vibration Maneuver on Cancer Patients' Satisfaction and their Pain Relief during Cannulation Insertion: A Randomized Controlled Trial
Public title
The Effect of Cold and Vibration Maneuver on Cancer Patients' Satisfaction and their Pain Relief during Cannulation Insertion
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Consent & compliance with all aspects of the clinical trial, methods, providing data during follow-up phase. Contact male & female patients with cancer, who are 18-70 years old at the time of the data collection phase
Exclusion criteria:
Involvement with any other ongoing studies. Medically diagnosed with psycho-mental diseases. Patients with anticipated difficult intravenous access, known sensitivity to cold (eg: Raynaud’s disease), sickle cell disease with extreme sensitivity to cold, patients who had any break or abrasion on the where device (cold and vibration)would be placed, or who had pre-existing pain (e.g., peripheral neuropathy, chronic pain, fractures over the placement site), No premedication analgesic and sedation was given, were topical or parenteral analgesics within (6) hours of presentation excluded.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 223
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random by using four cards blue, red, green, yellow put in the box the blue card represented cold (A group), red card for vibration (B group), green card for cold and vibration together (AB group), and yellow card for control (C group). Then all participant was allowed to choose one of these cards. No allocation concealment will be carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
To achieve single blind in this trial, the participant is kept blinded to their group assignment (interventions and control groups) throughout the study. The data collector administers the assigned intervention (cold, vibration, and together group) without revealing the participant's group assignment. The researcher retains knowledge of group allocation to ensure Single blind. Interventions are randomized, and the pain assess to rate pain intensity and satisfaction without knowing the type of maneuvers received, ensuring that participants' expectations do not influence the results. These procedures reduce the influence of prior expectations and ensure an effective study.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethical Approval Committee, at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
10661/8/1/3/1

Health conditions studied

1

Description of health condition studied
Pain and satisfaction of cancer patients during cannulation
ICD-10 code
M79.6
ICD-10 code description
Pain in limb, hand

Primary outcomes

1

Description
The primary outcome variable that may reduce level of pain and Improve patients' satisfaction during cannula insertion
Timepoint
Immediately during and after the intervention (cannula insertion), time is 1-3 minutes
Method of measurement
Visual analog scale for pain and satisfaction, VAS is the line 100 mm from 0-100 (end one of the line read “no pain” and at the other is “unbearable pain”. And for satisfaction “I’m very satisfied “ on one end “I’m not satisfied at all” on the other .

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (A): Vibration only, this group received vibration using a component of the Buzzy® device. After applying a tourniquet to the patient's wrist, a suitable vein was identified on the dorsum of the hand. The area for cannulation was then cleaned with an alcohol swab according to standard practice and allowed to dry. The vibrating component of the Buzzy device was secured to the wrist with tape, approximately 3-5 cm proximal (closer to the body) to the cannulation site. The device was turned on for 30-60 seconds before cannula insertion and remained on throughout the procedure. Once successful cannulation was achieved, the Visual Analog Scale (VAS) was used to measure the patient's pain intensity and satisfaction. The patient indicated their level of pain and satisfaction by pointing to a specific location on the VAS line. These scores were recorded separately.
Category
Treatment - Other

2

Description
Intervention group (B): Application Ice Wing only (frozen solid, a component of the Buzzy® device). Ensure the ice wing is frozen before application Equipment preparation for cannulation: A tourniquet was applied to the patient's wrist. Once a suitable vein was identified on the dorsum of the hand, the area overlying the vein was cleaned with an alcohol swab following standard practice and allowed to dry. The Ice Wing was applied only and fixed with tape (other component of the Buzzy device) to the wrist. It was placed approximately 3-5 cm proximal (closer to the body) to the site of cannula insertion for 30-60 seconds before cannula insertion and remained in place until the procedure was completed. After successful cannula insertion, the Visual Analog Scale (VAS) was used to measure pain intensity and satisfaction. The patient indicated a point on the VAS line that represented their perception of pain and satisfaction. These were assessed separately.
Category
Treatment - Other

3

Description
Intervention group (AB): Application the Buzzy® device with both components (ice wing frozen solid and vibration) together. Ensure the ice wing is frozen before application. Prepare cannulation equipment. Apply a tourniquet to the patient's wrist. Once a suitable vein is identified on the dorsum of the hand, clean the area to be cannulated with an alcohol swab following standard practice and allow it to dry completely. Attach the ice wing through the elastic strap on the back of the Buzzy device. Place the device on the patient's wrist and fixed with tape. Activate the vibration component on the Buzzy device and position it on the wrist, approximately 3-5 cm proximal (closer to the body) to site cannula insertion. Turn it on for 30-60 seconds before cannula insertion and continue using it throughout the procedure. After successful cannula insertion, measure pain intensity and satisfaction using the Visual Analog Scale (VAS). The patient indicated a point on the VAS line that represented their perception of pain and satisfaction. These were assessed separately.
Category
Treatment - Other

4

Description
Control group: Subjects in the control group with cancer underwent cannula insertion. No intervention was provided during the study. After successful first-attempt cannulation, pain intensity and satisfaction were measured using a VAS (Visual Analogue Scale). The patient indicated a point on the VAS line that represented their perception of pain and satisfaction. These were assessed separately.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Oncology Center in Al- Habobi Teaching Hospital in Thi-Qar Nasseryia City.
Full name of responsible person
Alaa Jawad Kadhim, Alaa Kareem Aziz
Street address
Baghdad, Street 729
City
Baghdad
Postal code
10001
Phone
+964 1 415 0076
Fax
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://www.medicalcity.gov.iq/ar/contact-us

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
College of Nursing / University of Baghdad
Full name of responsible person
Professor. Wissam Jabbar Qasim, PhD. Dean
Street address
Bab AL-Muadum campus
City
Baghdad
Postal code
10001
Phone
+964 1 521 1494
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The authors of the trial are the funding source
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
University of Baghdad/College of Nursing
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848

Person responsible for scientific inquiries

Contact
Name of organization / entity
College of Nursing/ University of Baghdad
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://mapcarta.com/30678848

Person responsible for updating data

Contact
Name of organization / entity
College of Nursing/ University of Baghdad
Full name of responsible person
Alaa Jawad Kadhim
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursing
Street address
Baghdad, Street 729
City
Baghdad
Province
Alrusafa
Postal code
10045
Phone
+964 770 352 0314
Email
alaaj@conursing.uobaghdad.edu.iq
Web page address
https://en.conursing.uobaghdad.edu.iq/

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
God willing, once finishing the process of data collection, analysis, and successful publishing of the manuscript, all the related files will become available for five months after the publications, after you are approved to register on the Iranian clinical trials website
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission and acknowledging his contribution
From where data/document is obtainable
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: alaaj@conursing.uobaghdad.edu.iq
What processes are involved for a request to access data/document
The processes involved in accessing this documentation are possible via email: alaaj@conursing.uobaghdad.edu.iq, the first and last name of authors, trial' title variable and the trial Id.
Comments
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors. The four groups were added individually in each field. We hope that the modifications will be appropriate to the design of the experiment. With many thanks and appreciation for your patience.
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