Comparison the effect of the application of Benson relaxation technique and supplemental oxygen therapy and their combination on anxiety and chemotherapy-induced nausea and vomiting in patients with gastric cancer
Determining and comparing the effect of the application of Benson relaxation technique and supplemental oxygen therapy and their combination on anxiety and chemotherapy-induced nausea and vomiting in patients with gastric cancer in Imam Khomeini Teaching Hospital in Urmia in 2020
Design
four-group clinical trial, 2 * 2 factorial design, convenient sampling, sample size will include 100 patients, block allocation.
Settings and conduct
One week before the start of the first course of chemotherapy, patients in all four groups complete the Nausea and Vomiting Index and the Self Anxiety Scale. Then patients in groups A and B perform Benson relaxation technique at home twice a day for 10 to 15 minutes. Patients in groups A and C receive 5 liters of oxygen per minute through the nasal cannula during chemotherapy. The severity of nausea and vomiting in all four groups will be assessed and compared immediately after chemotherapy, 24 hours, 2, 3, 4, and 5 days after chemotherapy session.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with gastric cancer based on medical records
Being in the first period of receiving injectable chemotherapy drugs
The use of chemotherapy drugs with side effects of nausea and vomiting, mild to severe
Hospitalization for chemotherapy
No concomitant radiotherapy
Willingness to participate in the study
Ability to communicate
Having a minimum literacy
Exclusion criteria:
Not wanting to continue to participate in the project
Intervention groups
The implementation of Benson relaxation technique, supplemental oxygen therapy and a combination of Benson relaxation technique with supplemental oxygen therapy. The control group will receive routine care.
Main outcome variables
Nausea and vomiting; The anxiety.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180808040742N3
Registration date:2020-12-08, 1399/09/18
Registration timing:prospective
Last update:2020-12-08, 1399/09/18
Update count:0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Yaser Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 7978
Email address
y.moradi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of the application of Benson relaxation technique and supplemental oxygen therapy and their combination on anxiety and chemotherapy-induced nausea and vomiting in patients with gastric cancer
Public title
Comparison of Benson relaxation technique and supplemental oxygen therapy and their combination on anxiety and chemotherapy-induced nausea and vomiting in patients with gastric cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gastric cancer based on medical records
Being in the first period of receiving injectable chemotherapy drugs
The use of chemotherapy drugs with side effects of nausea and vomiting, mild to severe
Hospitalization for chemotherapy
Lack of known mental illness including severe depression (based on patient medical history records)
No brain malignancy
No chronic obstructive pulmonary disease
No drugs and alcohol
No concomitant radiotherapy
No inner ear disorder
Willingness to participate in the study
Ability to communicate
Having a minimum literacy
Exclusion criteria:
Not wanting to continue to participate in the project
Go to travel
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block allocation will be done and based on the factors affecting nausea and vomiting (type of chemotherapy drug and patient gender). For each study group, two male and female blocks and 4 blocks in terms of nauseating severity of chemotherapy drugs (high, moderate, low, minimum possible amount) will be considered. Accordingly, there will be 8 arms in each group. The first patient from each block will be randomly assigned to one of four groups.
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 Urmia University of Medical Sciences
Street address
Vice-chancellor for research of Urmia University of Medical Sciences, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-07-19, 1399/04/29
Ethics committee reference number
IR.UMSU.REC.1399.205
Health conditions studied
1
Description of health condition studied
Gastric cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
One week before the start of the first course of chemotherapy, immediately, 24 hours, 2, 3, 4 and 5 days after the chemotherapy session
Method of measurement
Self Anxiety Scale
2
Description
Nausea and Vomiting
Timepoint
One week before the start of the first course of chemotherapy, immediately, 24 hours, 2, 3, 4 and 5 days after the chemotherapy session
Method of measurement
Rhodes Index of Nausea and Vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: The intervention includes Benson relaxation technique and complementary oxygen therapy.
Category
Treatment - Other
2
Description
Intervention group B: The intervention is Benson relaxation technique.
Category
Treatment - Other
3
Description
Intervention group C: The intervention is complementary oxygen therapy.