NCT06712056

Brief Summary

This quasi-experimental study with a pretest-posttest control group will be conducted to determine the effect of a mindfulness-based stress reduction program on spiritual well-being and the meaning of life among the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration 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

Study Start

First participant enrolled

October 27, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

November 20, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

Mindfulness,NursingStressSpirituality.

Outcome Measures

Primary Outcomes (2)

  • Standardized Mini Mental Test

    In this study, elderly individuals, who scored at least 23 and at most 30 on the Standardized Mini Mental Test were included

    pretraining

  • Survey Form

    The form prepared by the reseearchers consisted of 13 questions, including personal characteristics, developed based on a literature review

    pretraining

Secondary Outcomes (2)

  • Spiritual Well Being Scale

    post-training at the 1st and 3rd months]

  • Meaning in Life Scale

    post traninig at the 1st and 3rd months

Study Arms (2)

Arm and İnterventional

EXPERIMENTAL

MBSR training will be given to this experimental group. To assess the cognitive status of the elderly, the "Standardized Mini-Mental State Examination" was used for those with primary or higher education levels, and the "Standardized Mini-Mental State Examination for the Uneducated" for those without primary education. Only elderly individuals scoring 23 or above on the Mini-Mental State Examination were included in the study. The elderly participants received mindfulness training (8 sessions), and personal questionnaire forms, the Spiritual Well-Being Scale, and the Meaning in Life Scale were administered before the intervention and post-intervention (at the 1st and 3rd months).The training is include awareness, staying in the moment, awareness of body, emotion, thought and environment, and breathing exercise techniques.

Behavioral: Mindfulness

İnterventional

NO INTERVENTION

MBRS training will not be given to this control group

Interventions

MindfulnessBEHAVIORAL

study of focusing attention

Also known as: awereneses training, breathing awareness study.
Arm and İnterventional

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years or older,
  • Living in the nursing home where the research will be conducted,
  • Being competent to continue the health education program,
  • Getting at least 23 points from SMMT
  • No hearing-visual impairment,
  • Being literate,
  • Volunteering to participate in research.

You may not qualify if:

  • Having a communication barrier,
  • Being diagnosed with dementia,
  • Not having attended any session of the eight-session training program,
  • Getting a score lower than 23 points from SMMT,
  • Having psychosis or mental disability that may cause cognitive impairment,
  • Do not have a terminal illness.
  • Not having participated in any of the Pretest, Posttest-1 and Posttest-2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing

Aydin, 09000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melek Yasemin Sevimoğlu

    Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing

    STUDY CHAIR
  • Filiz Adana, prof

    Aydın Adnan Menderes University, Faculty of Nursing, Devision Public Health Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: quasi-experimental study with a pretest posttest controlgroup design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public Health Nurse

Study Record Dates

First Submitted

November 20, 2024

First Posted

December 2, 2024

Study Start

October 27, 2022

Primary Completion

August 17, 2023

Study Completion

November 17, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request

Shared Documents
CSR
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request

Locations