Clinical trial NCT05187130: The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients
Official title: The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients: Single Blinded Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Cancer
Keywords: Stress, Psychological
Depression
Anxiety Disorders
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.

Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.

Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or practice (intervention?) on anxiety, tension, depression symptoms and coping with stress were included in the study. Participitants randomised intervention and controlled groups.

Detailed description: Study design A single blinded, randomized controlled experimental design was used. The study complied with guidelines outlined under the Consolidated Standards of Reporting Trials (CONSORT) checklist.

Sample and Participants The study was carried out in July-December 2021 with the participation of cancer patients who were treated at a university hospital in Istanbul/Turkey.

Inclusion criteria; Patients aged 18 and over, volunteering to participate in the study, conscious and without communication problems, who did not take any course or intervention on anxiety, tension, depression symptoms and coping with stress were included in the study.

Sample size and randomization The sample number was calculated using the GPower 3.1.9 version program. At an effect size of 0.5 and an error level of 0.05 \[alpha\], the required sample size was determined to be at least 54 individuals for each group. A power analysis was performed considering the number of samples and the values of the data obtained from a similar study in the literature (Lee et al., 2020). The power of the analysis made with this sample size was determined as 93.1%. Considering the losses during the study, the sample number for each group was determined as 60 people.

The groups of participants who agreed to participate in the study were determined by the program with the randomization URL http://www.randomization.com/. In order to distribute the numbers to the groups, the numbers from 1 to 120 were randomly assigned to the two groups, assuming that set 1 would represent the intervention group and set 2 would represent the control group. In line with the program, the order of the patients forming the sample group was determined by randomization. A total of 130 patients, 65 in the intervention group and 65 in the control group, were included in the study. 5 participants in the intervention group who did not want to participate and died during the study, and 5 participants in the control group who did not want to participate and died during the study were not included in the evaluation. In the study, the results of a total of 120 patients, 60 in the intervention group and 60 in the control group, were analyzed.

Measures/Instruments Participant Information Form, State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale were used to collect research data. Survey Monkey was used as the data collection method. The Survey Monkey survey was created, which provides self-access and makes it easier to collect and track data by preventing multiple data entries from the same person. Confidentiality was ensured by completely disabling electronic and IP address registrations to receive anonymous responses.

Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* volunteering to participate in the study,
* conscious and not having communication problems,
* not taking any course on anxiety, tension, depression symptoms and coping with stress

Exclusion Criteria:

* Diagnosed with a known psychiatric illness (delirium, anxiety, panic attack, depression) • Take another psychological relaxation course or training

Primary outcomes:
measure: Information Form
timeFrame: Baseline
measure: State Anxiety Inventory
timeFrame: Baseline
measure: State Anxiety Inventory
timeFrame: at the end of week 1
measure: Psychological Well-Being Scale
timeFrame: baseline
measure: Psychological Well-Being Scale
timeFrame: at the end of week 1
measure: Beck Depression Inventory
timeFrame: baseline
measure: Beck Depression Inventory
timeFrame: at the end of week 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
Study officials:
affiliation: Istanbul Aydın University
name: Dilek YILDIRIM, Ph.D
role: STUDY_DIRECTOR
References: