IRCT | The effect of a web-based Benson relaxation training program on the sleep quality and pain intensity of cancer patients referred to the Chemotherapy Center of Jahrom University of Medical Sciences.

Protocol summary

Study aim: The effect of Benson's relaxation technique on pain intensity and sleep quality in cancer patients
Design: This clinical trial design has a control group, with parallel, one-sided blind, randomized groups, 52 patients were selected by available sampling method.
Settings and conduct: This clinical trial study will be conducted on 52 cancer patients receiving chemotherapy aged 20-80 years old, who will be selected by the available sampling method and will be randomly assigned to control and intervention groups using a computer. It was a blind strain that only the researcher knows about the type of intervention
Participants/Inclusion and exclusion criteria: Entry requirements: • Willingness to participate in research • Being literate in reading and writing • Having a smart mobile phone • Definitive diagnosis of cancer by an oncologist and receiving chemotherapy Exit conditions: • Any psychological disorders • Regular sports activity • Having concomitant diseases such as heart attack or stroke in the previous three months • Use of sleeping pills and painkillers.
Intervention groups: Educational program for 25 participants of the intervention group in the form of virtual training in ETA or Soroush software in four virtual sessions that include familiarization with types of cancers, symptoms and diagnostic methods - treatment and care - nutrition and exercise - ways to cope with the disease and improve the quality of life virtually will be executed. After this file is voiced and Benson's relaxation training is uploaded to the group twice a day for eight weeks. The day after uploading the educational file, the researchers follow up with patients by phone and SMS to ensure that all patients have viewed and read the sent file. During the research period, educational intervention is not carried out in the control group.
Main outcome variables: Pain intensity and sleep quality

General information

Reason for update
Acronym: -
IRCT registration information: IRCT registration number: IRCT20211121053137N2

Registration date: 2023-12-20, 1402/09/29

Registration timing: prospective

Last update: 2023-12-20, 1402/09/29

Update count: 0
Registration date: 2023-12-20, 1402/09/29

Registrant information: Name

Afrooz Rahmanian

Name of organization / entity

The university of Shiraz

Country

Iran (Islamic Republic of)

Phone

+98 71 5427 6232

Email address

rahmaniannurse1395@gmail.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2023-12-21, 1402/09/30
Expected recruitment end date: 2023-12-25, 1402/10/04
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of a web-based Benson relaxation training program on the sleep quality and pain intensity of cancer patients referred to the Chemotherapy Center of Jahrom University of Medical Sciences.

Public title: Benson's relaxation training program on sleep quality and pain intensity in cancer patients
Purpose: Supportive
Inclusion/Exclusion criteria: Inclusion criteria:

• Desire to participate in research• Being literate in reading and writing• Having a smart phone• Definitive diagnosis of cancer by an oncologist and receiving chemotherapy

Exclusion criteria:

• Any psychological disorders• Regular sports activity• Having concomitant diseases such as heart attack or stroke in the previous three months• Use of sleeping pills and painkillers
Age: From 20 years old to 80 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Data analyser

Sample size

Target sample size: 52

Randomization (investigator's opinion)

Randomized

Randomization description

52 participants were selected by available sampling method. Then they were randomly divided into intervention and control groups. The intervention and control groups were named A and B, and then 52 random numbers were selected using a computer. Numbers from 0 to 4 or those with 0-4 as their first digit were assigned to group A, while numbers 5 to 9 or those with 5-9 as their first digit were assigned to group B.

Blinding (investigator's opinion)

Single blinded

Blinding description

The participants who were in the intervention and control groups and the data analysts, were blinded and were not in progress

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of Jahrom University of Medical Sciences

Street address

Motahari Blvd., Farhangtown

City

Jahrom

Province

Fars

Postal code

7414845794
Approval date: 2023-10-28, 1402/08/06
Ethics committee reference number: IR.JUMS.REC.1402.081

Health conditions studied

1

Description of health condition studied: Cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Sleep quality score
Timepoint: The beginning of the study (before the start of the intervention) and the end of the study and two months after the end of the study
Method of measurement: Petersburg Sleep Quality Questionnaire

2

Description: Pain intensity score
Timepoint: The beginning of the study (before the start of the intervention) and the end of the study and two months after the end of the study
Method of measurement: NRS pain intensity scale

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: The training program is sent as a training file in four sessions in the virtual training group in Ita or Soroush for 26 people, and the training content of these four sessions includes: getting to know the types of cancers - diagnostic methods - treatment and care - nutrition, exercise - ways to deal with the disease and Improving the quality of life. Then, the voiced file of Benson's relaxation and its method is loaded twice a day in the group for up to eight weeks.
Category: Lifestyle

2

Description: Control group: During the research period, the control group receives their previous treatments and training.
Category: Other

Recruitment centers

1

Recruitment center: Name of recruitment center

Chemotherapy ward, Peymanieh hospital

Full name of responsible person

Rahmanian Afrooz

Street address

Valiasr Square, Peymaniye Hospital

City

Jahrom

Province

Fars

Postal code

Phone

+98 71 5412 0010

Fax

Email

Rahmaniannurse1395@gmail.com

Web page address

http://www.jums.ac.ir

1

Sponsor: Name of organization / entity

Jahrom University of Medical Sciences

Full name of responsible person

Research Assistant of the University of Medical Sciences

Street address

, University of Medical Sciences, Ostad Motahari St.

City

Jahrom

Province

Fars

Postal code

74148-46199

Phone

+98 71 5434 0405

Fax

Email

Rahmaniannurse1395@gmail.com

Web page address

http://www.jums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Jahrom 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

Jahrom University of Medical Sciences

Full name of responsible person

Badiyepeymaie Jahromi Zohreh

Position

Associate professo

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Motahari Blvd., Nursing Faculty

City

Jahrom

Province

Fars

Postal code

7414785318

Phone

+98 71 5437 2000

Email

rahmaniannurse1395@gmail.com

Web page address

http://www.jahromu.ac.ir/

Person responsible for scientific inquiries

Contact: Name of organization / entity

Jahrom University of Medical Sciences

Full name of responsible person

Badiyepeymaie Jahromi Zohreh

Position

Associate professor

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Motahari Blvd., Nursing Faculty

City

Jahrom

Province

Fars

Postal code

7414785318

Phone

+98 71 5437 2000

Email

z.badiyepeyma@gmail.com

Web page address

http://www.jahromu.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Jahrom University of Medical Sciences

Full name of responsible person

Rahmanian Afrooz

Position

Nurse

Latest degree

Master

Other areas of specialty/work

Nursery

Street address

Paymaneh hospital

City

Jahrom

Province

Fars

Postal code

۷۴۱۹۸۸۶۶۸۸

Phone

009871541230010

Fax

Email

Rahmaniannurse1395@gmail.com

Web page address

http://www.jahromu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be 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: Undecided - It is not yet known if there will be a plan to make this available
Analytic Code: Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available

The effect of a web-based Benson relaxation training program on the sleep quality and pain intensity of cancer patients referred to the Chemotherapy Center of Jahrom University of Medical Sciences.