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The Effect of Mindfulnes Program on Stress, Depression and Psychological Well-being in Cancer Patients

I

Istanbul Aydın University

Status

Completed

Conditions

Neoplasms
Cancer

Treatments

Other: Mindfulness

Study type

Interventional

Funder types

Other

Identifiers

NCT05187130
Cancer patients mindfulness

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

Intervention
Experimental group
Description:
Mindfulness-based breathing and music therapy
Treatment:
Other: Mindfulness
Control
No Intervention group
Description:
No intervention has been made

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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