Exploring how to improve fear and anxiety resulting from cancer through spiritual mindfulness.
Design
This clinical trial is a single-arm pre-post assessment study. The sample size is 50 people.
Settings and conduct
This clinical trial study is of the single-arm type, assessing before and after. Interviews are conducted with women. Their fear and anxiety are identified in three stages: diagnosis, treatment, and recovery. Based on that, spiritual monitoring sessions are recorded and made available to women. Questionnaires are completed before and after listening to spiritual monitoring sessions. Interviews are conducted with women after listening to spiritual monitoring sessions.
Participants/Inclusion and exclusion criteria
Women aged 20 to 65 who are in one of the stages of cancer diagnosis, treatment, and recovery.
Intervention groups
This clinical trial is a single-arm pre-post assessment study
Main outcome variables
Spiritual well-being (EORTC QLQ-SWB32)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240409061454N1
Registration date:2024-05-07, 1403/02/18
Registration timing:prospective
Last update:2024-05-07, 1403/02/18
Update count:0
Registration date
2024-05-07, 1403/02/18
Registrant information
Name
Narges Rahmanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3237 1103
Email address
narges.rahmanian@res.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of how to improve fear and anxiety caused by cancer disease through spiritual meditation
Public title
The impact of spiritual meditation on cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants are exclusively women
In one of the three stages, they are in diagnosis treatment, and recovery
They are between 20 and 65 years old
Exclusion criteria:
Reluctance to continue the program
Hospitalization of participants
Having a serious mental illness
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee at the Research Department of Isfahan University of Medical Sciences - Alzahra Rese
Street address
Street Hazar Jarib, Isfahan University of Medical Sciences and Health Services, Building No. 4 - Deputy of Research and Technology University.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.ARI.MUI.REC.1402.290
Health conditions studied
1
Description of health condition studied
The effectiveness of spiritual meditation in cancer treatment
ICD-10 code
Z85.8
ICD-10 code description
Personal history of malignant neoplasms of other organs and systems
Primary outcomes
1
Description
Cancer patients often experience fear and anxiety. The aim of the study is to improve patients' fear and anxiety through spiritual mindfulness.
Timepoint
The questionnaire is filled in three stages before, after and two months after the intervention. Qualitative interview is done only after the intervention.
Method of measurement
QLQ_SWB32 questionnaire is used for quantitative part. In-depth interviews are used for the qualitative part.
Secondary outcomes
1
Description
With questionnaires and qualitative interviews, it is measured that spiritual meditation has been able to improve stress and anxiety.
Timepoint
The questionnaire is filled in three stages before, after and two months after the meditation sessions. Qualitative interview is done only after spiritual meditation sessions.
Method of measurement
The questionnaire is filled in three stages before, after and two months after the meditation sessions. Qualitative interview is done only after spiritual meditation sessions.
Intervention groups
1
Description
Clinical trial study, single-arm, pre and post assessment. A group of women aged 20-65, diagnosed with cancer in one of the stages of diagnosis, treatment, and recovery, are selected. We conduct qualitative interviews with them, asking about their psychological and emotional concerns and needs to identify their fears and anxieties. Based on these qualitative interviews, spiritual care sessions are designed and recorded by a psychiatrist. Our goal is to determine the impact of spiritual care on improving the fears and anxieties of the participants. Before listening to the spiritual care sessions, a questionnaire is filled out to understand the participants' status and the level of their fears and anxieties. After listening to the spiritual care sessions, the questionnaire is filled out again to determine the level of change and improvement. At this stage, alongside the questionnaire, qualitative interviews with the participants are conducted. Two months later, the questionnaire is filled out again.