The Effect of Cognitive and Laughter Therapy on Psychological Symptoms in Nursing Students

NCT06344624 | Completed DMC

• 1 other identifier: Mersin_U
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of high mental symptoms among nursing students in Turkey highlights the need to develop various support strategies in nursing education to preserve and ensure the continuity of the nursing workforce. This study aims to compare the effects of brief cognitive-behavioral group psychotherapy and laughter yoga on mental symptoms in nursing students with mental symptoms.

Conditions

Mental Health Issue

Keywords

Brief cognitive-behavioral group therapy; laughter yoga; mental symptoms; nursing students

Outcome Measures

Primary Outcomes (1)

• The change in mental symptoms will be assessed using the Brief Symptom Inventory.

  The scale consists of 53 Likert-type items. Items are scored on a scale of 0 to 4, corresponding to "not at all" and "very much," respectively. The higher the total score obtained from the scale, the more the individual's mental symptoms increase. It comprises nine subscales, three global indices, and additional items. The subscales are somatization, obsessive-compulsive disorder, interpersonal sensitivity, depression, anxiety disorder, hostility, phobic anxiety, paranoid ideation, and psychoticism, while additional items relate to eating disorders, sleep disturbances, thoughts of death and suicide, and feelings of guilt.

  Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and and 4 weeks later the end of the 6th season (T2).

Secondary Outcomes (2)

• Psychological resilience will be assessed using the Psychological Resilience Scale.

  Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and 4 weeks later the end of the 6th season (T2).

• Negative self-evaluations and thought patterns will be assessed using the Automatic Thoughts Scale.

  Changing from at baseline (pretest- T0) and right after the end of the 6th season (post test- T1) and 4 weeks later the end of the 6th season (T2).

Study Arms (2)

Cognitive Behavioral Therapy Group

ACTIVE COMPARATOR

In the first sessions, less time was allotted to the introductory phase because it was anticipated that students would face similar issues in terms of age, gender, and academic standing, and that their depressive symptoms would be milder than those of clinical patient groups. Additionally, more intensive short-term cognitive behavioral therapy (b-CBT) was preferred. Six sessions, two per week for three weeks, lasting sixty minutes each, were planned, with four groups of eight to twelve students based on course schedules. A researcher with a doctorate in mental health nursing and certification in CBT will oversee CBT. The program aims to enhance students' mindful awareness. Key CBT techniques will include breath-body awareness, coping methods for emotional and physical depression symptoms (breathing and attention exercises), recognizing thought-emotion-behavior interactions, cognitive restructuring, and future planning.

Behavioral: CBT group

Laughter Yoga Therapy Group

ACTIVE COMPARATOR

There will be a certified researcher leading the laughter yoga sessions. Laughter yoga will ideally allow participants to sit comfortably in front of each other's eyes. Six sessions, two per week for three weeks, lasting sixty minutes each, were planned, with four groups of eight to twelve students based on course schedules. Laughter yoga consists of four parts: deep breathing exercises, warm-up exercises, playful activities, and laughter exercises.

Behavioral: Laughter group

Interventions

CBT group BEHAVIORAL

Brief cognitive behavioral therapy

Cognitive Behavioral Therapy Group

Laughter group BEHAVIORAL

Laughter yoga therapy

Laughter Yoga Therapy Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Currently enrolled in the nursing faculty between April 10, 2024, and June 2, 2024.
• Scored within the top 20% on the Brief Symptom Inventory for mental symptom scores.
• Voluntarily agree to participate in the study and have signed the Informed Consent Form.
• Understand and comprehend Turkish language

You may not qualify if:

• Having received cognitive behavioral therapy previously.
• Undergoing psychological or psychiatric treatment.
• Underwent surgical procedures in the last three months.
• Having chronic illnesses requiring regular medication use.
• Having glaucoma or hernia conditions.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Turkey, Mersin University

Mersin, 33180, Turkey (Türkiye)

Location

Study Officials

• EMİNE ÖNCÜ

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using the block randomization technique, the sampled students will be split into two groups: the CBT group and the laughter group. Six will be the block size. Excel will be used to create blocks (allocation concealment) and random numbers will be generated by an assistant researcher who does not attend therapy sessions. The purpose of the program is to support mental health and evaluate its effectiveness; students will not be informed about which group they are in (participant blinding). Research data will be coded as A and B and entered into the computer database by someone other than the researchers conducting the therapy sessions, and statistical analysis will be performed using this coding (statistician blinding).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Model Details: A randomized controlled trial with a pretest-posttest design

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 3, 2024
• Study Start: April 10, 2024
• Primary Completion: June 2, 2024
• Study Completion: June 12, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: October through December of 2024
• Access Criteria: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

Locations

TU (1)