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

NCT05187130 | Completed

• 1 other identifier: Cancer patients mindfulness
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Cancer

Keywords

Stress, Psychological; Depression; Anxiety Disorders

Outcome Measures

Primary Outcomes (7)

• Information Form

  This form was developed by the researchers to include the age, gender, marital status, educational status, and treatment method of the participants.

  Baseline

• State Anxiety Inventory

  The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).

  Baseline

• State Anxiety Inventory

  The State Anxiety Inventory was developed by Spielberger et al. in 1970 to determine the state anxiety levels of individuals. Turkish reliability and validity studies of the inventory were carried out by Öner and Le Compte (1983). The State Anxiety Inventory measures anxiety in adults. In the 20-item State Anxiety Inventory, the total score obtained from the four-point Likert-type inventory for each item can vary between 20 and 80. A high score indicates a high level of anxiety, while a small score indicates a low level of anxiety (Spielberger, et al., 1970; Öner \& Le, 1983). Possible scores on the Scale range from 0 to 19 points (interpreted as meaning no state anxiety), 20 to 39 points (mild), 40 to 59 points (moderate), 60 to 79 points (severe), and 80 points and above ( very severe state anxiety).

  at the end of week 1

• Psychological Well-Being Scale

  The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.

  baseline

• Psychological Well-Being Scale

  The scale, which was developed by Diener, Scollon, and Lucas, (2009) to measure the level of psychological well-being, has eight items. It identifies important elements of human function, from positive relationships to feelings of efficacy to having a meaningful and purposeful life. The Turkish validity and reliability of the scale was made by Telef in 2013. Scale items are answered between 1 and 7, as I strongly disagree (1) to I strongly agree (7). All items are expressed positively. Scores range from 8 (strongly disagree to all items) to 56 (strongly agree to all items). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.87. A high score from the scale indicates that the person has good psychological strength.

  at the end of week 1

• Beck Depression Inventory

  Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.

  baseline

• Beck Depression Inventory

  Beck et al. The validity and reliability study of the scale developed by Hisli in 1988 was carried out by Hisli. It is a depression rating scale consisting of 21 questions in total, evaluated by adding the scores between 0-3 obtained from each answer. Scale in line with the corresponding score intervals; 1-10 normal, 11-16 moderate mood disorder, 17-20 clinical depression; It is grouped as moderate depression between 21-30, severe depression between 31-40, and severe depression between 41-63.

  at the end of week 1.

Study Arms (2)

Intervention

EXPERIMENTAL

Mindfulness-based breathing and music therapy

Other: Mindfulness

Control

NO INTERVENTION

No intervention has been made

Interventions

Mindfulness OTHER

60 patients in the mindfulness-based breathing and music therapy group were divided into subgroups of 5 participants each. Each 6-person group started by having participants complete the pretest State Anxiety Inventory, Beck Depression Inventory, and Psychological Well-Being Scale via Survey Monkey. Mindfulness-based breathing and music therapy was applied to each patient group in approximately 45-minute sessions per day. At the end of the session, participants re-filled the posttest State Anxiety Inventory, Work-Related Tension Scale, and Psychological Well-Being Scale. A total of 3 sessions were completed with an interval of two days.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Stress, Psychological; Depression; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dilek YILDIRIM, Ph.D

  Istanbul Aydın University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor Dr.

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 11, 2022
• Study Start: July 20, 2021
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

TU (1)