NCT06754683

Brief Summary

The study aims to determine the impact of self-compassion-based psycho-education on supporting nursing students in managing stress, improving their resilience, and enhancing their self-compassion and psychological well-being (PWB). Self-compassion involves being kind to oneself during challenging times; it provides practical tools and knowledge to enhance personal growth and resilience. By participating in this program, nursing students may learn strategies to improve their coping with the pressure of studies, build emotional strength, and improve their psychological well-being. The study will measure the participants' levels of self-compassion, stress, resilience, and psychological well-being using a validated questionnaire before and after participation in the program and compare them to determine the program's impact on the abovementioned variables.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2025

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

December 23, 2024

Last Update Submit

April 7, 2026

Conditions

Keywords

Self-compassionStressResiliencePsychological Well-beingNursing Students

Outcome Measures

Primary Outcomes (2)

  • Change in self-compassion score as measured by state self-compassion scale (SSCS-L)

    Self-compassion score as measured by the SSCS-L, is a 5 rating scale with 1= not at all true for me to 5= Very true for me with a total of 18 items that can assess total (composite) self-compassion score as well as the six (kindness, self-judgment, mindfulness, over-identification, common humanity and isolation) individual elements of self-compassion. To compute a total state self-compassion score: the investigators will take the mean of each subscale, to compute a total mean (the average of the six subscale means as suggested by the scale authors). The score cut-off point is 1.0-2.49 to be low, 2.5-3.5 to moderate, and 3.51-5.0 to be high. When examining subscale scores, higher scores on the self-judgment, isolation, and over-identification scale indicate less self-compassion before reverse-coding, and more self-compassion after reverse coding.

    Baseline, 8 Weeks

  • Psychological well-being score as measured by brief inventory of thriving scale (BITS)

    Psychological well-being score as measured by brief inventory of thriving scale, it is a 5 Likert rating scale with 1= totally disagree to 5= totally agree with a total of 10 items. The scores cut off point is 1.0-2.49 to be low, between 2.5-3.5 to be moderate, and 3.51-5.0 to be high.

    Baseline, 8 Weeks

Secondary Outcomes (2)

  • Change in stress score as measured by student nurse stress index scale (SNSI)

    Baseline, 8 Weeks

  • Change in resilience score as measured by Connor-Davidson-Resilience-Scale (CD-RISC-10 scale).

    Baseline, 8 Weeks

Study Arms (2)

Self-compassion based psycho-education intervention

EXPERIMENTAL

8-week Self-compassion based psycho-education intervention

Behavioral: 8 weeks Self-compassion based psycho-education

Wait-list control group

NO INTERVENTION

A pre-test will be conducted in the first week and the post-test in the 8th week.

Interventions

The Self-compassion psychoeducational intervention will be utilized as the intervention in this study will be delivered by the first investigator and supervised by the Principal investigator, who has experience in mindfulness and self-compassion practices. It will consist of eight weekly 1.5 hours of face-to-face sessions and 1 hour each week of online sessions. Each session will be according to a specific topic that will cover the objectives of the study, incorporating the concept of self-compassion interventions based on the research literature and input from experts in the field, taking into consideration the needs of the participants. Participants will be required to have at least 80% of attendance for intervention completion.

Self-compassion based psycho-education intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • International students of Nursing Faculty
  • The participants should be able to communicate effectively using the English language.
  • Participants did not participate in self-compassion -based training before
  • The subject has commenced clinical posting and experience.
  • Participants with low self-compassion score in the preliminary survey

You may not qualify if:

  • Participants receiving psychotherapy
  • Participants who are currently enrolled in any online or face-to-face stress management training or course.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Near East University, Turkey

Yakın Doğu Bulvarı, Mersin 10, 99138, Turkey (Türkiye)

Location

Related Publications (10)

  • Klainin-Yobas P, Vongsirimas N, Ramirez DQ, Sarmiento J, Fernandez Z. Evaluating the relationships among stress, resilience and psychological well-being among young adults: a structural equation modelling approach. BMC Nurs. 2021 Jul 5;20(1):119. doi: 10.1186/s12912-021-00645-9.

    PMID: 34225712BACKGROUND
  • Kilic A, Hudson J, McCracken LM, Ruparelia R, Fawson S, Hughes LD. A Systematic Review of the Effectiveness of Self-Compassion-Related Interventions for Individuals With Chronic Physical Health Conditions. Behav Ther. 2021 May;52(3):607-625. doi: 10.1016/j.beth.2020.08.001. Epub 2020 Aug 13.

    PMID: 33990237BACKGROUND
  • Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.

    PMID: 18157881BACKGROUND
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND
  • Huang, J., Lin, K., Fan, L., Qiao, S., & Wang, Y. (2021). The effects of a self-compassion intervention on future-oriented coping and psychological well-being: A randomized controlled trial in Chinese college students. Mindfulness, 12, 1451-1458. https://doi.org/10.1007/s12671-021-01614-8

    BACKGROUND
  • Jones, M. C., & Johnston, D. W. (1999). The derivation of a brief Student Nurse Stress Index. Work & Stress, 13(2), 162-181. https://doi.org/10.1080/026783799296129

    BACKGROUND
  • Neff, K. D., Tóth-Király, I., Knox, M. C., Kuchar, A., & Davidson, O. (2021). The Development and Validation of the State Self-Compassion Scale (Long-and Short Form). Mindfulness, 12(1), 121-140. https://doi.org/10.1007/s12671-020-01505-4

    BACKGROUND
  • Su R, Tay L, Diener E. The development and validation of the Comprehensive Inventory of Thriving (CIT) and the Brief Inventory of Thriving (BIT). Appl Psychol Health Well Being. 2014 Nov;6(3):251-79. doi: 10.1111/aphw.12027. Epub 2014 Jun 12.

    PMID: 24919454BACKGROUND
  • Tung, L. N. (2020). Using Mindful Self-Compassion (MSC) as a Strategy to Reduce Stress and Develop Self-Compassion in Nursing Students (Order No. 27837495). Available from ProQuest Dissertations & Theses Global. (2458948204). https://www.proquest.com/dissertations-theses/using-mindful-self-compassion-msc-as-strategy/docview/2458948204/se-2

    BACKGROUND
  • Yang Z, Tse MMY, Huang H, Fang H, Chung JWY, Chong DYK, Wong TKS. Evaluating the feasibility and preliminary effects of an online compassion training program for nursing students: A pilot randomized controlled trial. Int J Nurs Sci. 2024 Aug 12;11(4):421-428. doi: 10.1016/j.ijnss.2024.08.007. eCollection 2024 Sep.

    PMID: 39830914BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • SAMINEH ESMAEILZADEH, PhD

    Near East University, Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: After the study period for the intervention group, the control group will be switched to the intervention group for the same period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 1, 2025

Study Start

March 26, 2025

Primary Completion

August 2, 2025

Study Completion

August 2, 2025

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The individual participant data (IPD) sharing plan in this study includes a detailed study protocol, available upon request after the publication of the results. A statistical plan outlining the methods and analysis used to address objectives will be available after the publication of the results in peer-reviewed journal. The unidentified consent form explaining the study purpose, procedures, possible risks, and participants' rights will be available upon request and institutional review board (IRB) approval. After completing the studies, the analytic code for data cleaning and statistical analysis will be made available upon reasonable request. IPD will be shared within 6-12 months after the publication of results in a peer-reviewed journal; it will also be shared through secure online repositories (clinicalTrials.gov) and Near East University (NEU) library repository; data access requires a data use agreement and a summary of research objectives, evaluated for ethical compliance.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
IPD will be shared within 6-12 months after the publication of results in a peer-reviewed journal
Access Criteria
Researchers and participants will be able to access data on all collected IPD and all IPD that underlie results in the result publication of this study

Locations