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To Determine the Impact of Self-compassion InterventionNCT06754683

The Effect of Self-Compassion Interventions on Nursing Students' Stress, Resilience, and Psychological Well-Being

A study testing 8 weeks Self-compassion based psycho-education in people with To Determine the Impact of Self-compassion Intervention, run by Near East University, Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
8 weeks Self-compassion based psycho-education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteTurkey (Türkiye)
Study dates
26 Mar 2025to 2 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Near East University, Turkey

    Yakın Doğu Bulvarı, Mersin 10, 99138

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Self-Compassion-Based Psycho-Education on Nursing Students' Self-Compassion, Stress, Resilience, and Psychological Well-Being

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.

Read the detailed description

The below standard operating procedures will be used to make sure that the study's patient recruitment, data collection, data management, data analysis, and reporting of adverse events are all done consistently and accurately in line with ethical standards: The inclusion and exclusion criteria, which specify the eligibility criteria, will guide the recruitment of participants. The recruitment process will use various student communication channels, such as emails, social media, and classroom announcements, to invite participants to the study. The investigators will provide study details to the participants before obtaining informed consent; demographic information about the participants and their recruitment status will be kept in secure folders. The investigators will use validated instruments before and after the intervention to measure self-compassion, stress, resilience, and psychological well-being, as approved by the ethics committee and data quality control procedures. The self-compassion-based psychoeducation will be delivered according to the protocol approved by the ethics committee. Participants' identities will be confidential and kept in secure password-protected systems for storing data; the investigators will conduct regular audits during data entry to ensure consistency and accuracy. Statistical Package software for social sciences, version 25, will be used for analysis as planned in collaboration with a statistical analysis expert to ensure accurate interpretation of the results. The participants will be given information and contact information of the investigators to report adverse events, such as any unexpected psychological distress during or after the program. The research team will document, follow up with the participants, and refer them to the university counseling center if necessary.

Using G power, the researchers carried out a-priori power analysis to determine the sample for the study since the literature search that the investigators conducted did not show any interventional study that assessed the effect of the self-compassion psycho-education intervention on self-compassion, stress, resilience, and psychological well-being, the investigators draw reference to methods used by Yip and Tong (2019) when conducting study, the researchers used the effect size results of self-compassion intervention meta-analysis of Zessin et al. (2015); the analysis found large effect size (g = 0.90) between self-compassion and well-being. The sample size required for 90% (1-β = 0.90) power at α=0.05 level for the assumption that the effect size will be large (d=0.90) in the study was calculated as 54 participants, 27 for each group, using G*Power 3.1.9.2 software, t-tests - repeated measures difference between two independent means analysis: A priori: Compute required sample size Input: Effect size d = 0.9, α err prob = 0.05, Power (1-β err prob) = 0.90, allocation ratio N2/N1 Output: noncentrality parameter λ = 3.30, Critical t = 2.00, df = 52, Total sample size = 54, actual power = 0.90. Considering the withdrawal rate (attrition rate) of 17% in a study of self-compassion intervention by Yang et al. (2024), the researchers calculated 17% of the calculated sample in this study (54/100 = 0.54 * 17 = 9.18, approximately 10). Therefore, the calculated sample size (54) and the addition of the computed attrition rate (10) will give a total of 64 participants (32 each for the intervention and the control group). Subjects will be recruited through convenience sampling.

To ensure the integrity and validity of results, the investigators will use validated data collection tools, conduct periodic checks during data collection, and maintain regular communication and simple explanations to participants to encourage complete and accurate responses. Investigators will regularly check the collected data for completeness and the data entries for further review and possibly record the type and extent of missing data in a log for transparency. Depending on the type of data missing, the investigators will handle it appropriately through coding, imputation technique, or exclusion criteria; the investigators will assess the pattern of the missing data and undertake sensitivity analysis to examine the impact of missing data on results and validate conclusions; the investigators will report all the above if it occurs to ensure transparency in handling missing data without altering participants' responses.

Evaluation of Data: All data will be analyzed using the study's Statistical Package for the Social Sciences (SPSS) version 25. Descriptive statistics (frequencies, percentages, mean, and standard deviation) will be used to describe the demographic data and summary of the scores of the state self-compassion scale long form (SSCS-L), stress, resilience, and PWB. For the impact of the intervention, a normality test will be conducted using the Kolmogorov-Smirnov test, and an appropriate statistical test will be applied after the test; for instance, an independent t-test will be utilized for between-group comparisons if the test satisfies the assumptions of a parametric independent t-test. The alternative nonparametric test (Mann-Whitney U Test) will be used if the assumption is unmet. For within-group comparisons, if the data satisfy the assumption of the parametric test, paired t-tests will be applied to assess changes in the intervention group between the pre-test and post-test, as well as those of the control group. The significance level will be set at p < 0.05; if the assumption of the parametric test (paired t-tests) is not met, a nonparametric alternative (Wilcoxon signed rank test) will be used, and the significance level will be set at p < 0.05.

Being tested
8 weeks Self-compassion based psycho-education
Keywords
Self-compassion, Stress, Resilience, Psychological Well-being, Nursing Students
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 8 weeks Self-compassion based psycho-educationBehavioural

    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.

Study groups in NCT06754683
Study groupRoleWhat they receive
Self-compassion based psycho-education interventionExperimental8-week Self-compassion based psycho-education intervention
Receives: Behavioral: 8 weeks Self-compassion based psycho-education
Wait-list control groupNo interventionA pre-test will be conducted in the first week and the post-test in the 8th week.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 8 Weeks

  2. 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.

    Measured: Baseline, 8 Weeks

Secondary outcomes (2)
  1. Change in stress score as measured by student nurse stress index scale (SNSI)

    Stress as measured by student nurse stress index scale, it is a 5 Likert rating scale with 1= Not stressful to 5= Extremely stressful with a total of 22 items. The SNSI is scored on a continuum, from not stressful (22) to extremely stressful (110)

    Measured: Baseline, 8 Weeks

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

    Resilience as measured by CD-RISC-10 scale, it is a 5 rating scale with 0= not true at all to 4= true nearly all the time, with a total of 10 items. The total of the rating will give a composite score that ranges from 0 to 40. Higher score rating will represent greater resilience while lower score will indicate low resilience.

    Measured: Baseline, 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study start26 Mar 2025
  3. Primary completion2 Aug 2025
  4. Study completion2 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
After the study period for the intervention group, the control group will be switched to the intervention group for the same period.
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06754683
Sponsor's protocol ID
NEU/2024/128-1889
Status last verified
Apr 2026
First submitted
23 Dec 2024
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 34225712
  • 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.

    PubMed 33990237
  • 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.

    PubMed 18157881
  • 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.

    PubMed 17695343
  • 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

  • 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

  • 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

  • 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.

    PubMed 24919454
  • 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

  • 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.

    PubMed 39830914

Questions about this trial

What is this clinical trial studying?

A study testing 8 weeks Self-compassion based psycho-education in people with To Determine the Impact of Self-compassion Intervention, run by Near East University, Turkey at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in self-compassion score as measured by state self-compassion scale (SSCS-L) (time frame: Baseline, 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06754683, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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