NCT04927923

Brief Summary

Chronic kidney failure (CRF) is an important health problem in the world and in our country. The use of hemodialysis as a treatment method has prolonged the life span of individuals with CRF; challenging and long treatment processes make the individual at risk for mental illnesses. It is an inevitable need to carry out psychosocial interventions to protect and improve the mental health of individuals, to ensure their adaptation to treatment processes, and to support them in coping with the difficulties they encounter. It is predicted that hope-focused motivational interviewing, which is a hope-enhancing intervention based on Snyder's Hope Theory, will be effective for individuals with low hope levels. In this study, it was aimed to evaluate the protocol suitability of the research. This study is a single blind, randomized controlled trial. The universe of the research will consist of 44 individuals coming for treatment in the Hemodialysis Unit. The study will be carried out in the Hemodialysis Clinic between September 2021 and December 2022. Within the scope of the protocol, a preliminary application was made with two individuals. Research data will be obtained by using sociodemographic data form, Depression Anxiety Stress Scale, Continuous Hope Scale. In the study, it was planned to apply hope-focused motivational interviews to the experimental group as one-hour sessions per week with face-to-face interviews for 8 weeks, while no intervention was made to the control group. Each session has goals and assignments for goals. Within the scope of the study, a hope tree will be created for everyone together with the patients to be used in the evaluation process of the interview sessions. Through the hope tree, it is aimed for the individual to set goals and discover the obstacles and solutions in reaching these goals. At the end of 8 weeks, the final test will be applied to the experimental and control groups. Following the post-test application, follow-up is planned at the end of the first month. The pre-application of the eight-week application protocol created for the purpose was made with two individuals. As a result of the preliminary application, it was observed that the stress, anxiety and depression levels of the individuals decreased and their hope levels increased. As a result of the preliminary application, it was concluded that the steps of the prepared application protocol were suitable for the study in line with the purpose determined with this patient group, and the protocol was transferred to the application phase as it was. It is thought that the results obtained from the research will contribute to the literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

June 9, 2021

Last Update Submit

January 29, 2024

Conditions

Keywords

HOPEPSYCIATRIC NURSINGMotivational Interview

Outcome Measures

Primary Outcomes (3)

  • Sociodemographic data form

    In this section, besides data such as age, gender, and educational status of the individuals, there are questions regarding the findings regarding the treatment process.

    immediately before the first interview

  • Depression Anxiety Stress Scale (DASS 21)

    The scale, which is a 4-point Likert type, consists of 7 questions each measuring "depression, stress and anxiety dimensions". consists of. An individual's depression sub-dimension 5 points or more, anxiety 4 points and above, stress A score of 8 or more indicates that it has a related problem.

    immediately before the first interview

  • Dispositional Hope Scale

    The scale, which is Likert type, consists of 12 items. It has 2 sub-dimensions, Alternative Ways Thinking and Acting Thinking, and there are 4 items for each sub-dimension. One of these items is for the past, two for the present and one for the future.The score obtained from the scale is an indicator of the hope level of the individual. An increase in scores is interpreted as an increase in the level of hope.

    immediately before the first interview

Secondary Outcomes (2)

  • Depression Anxiety Stress Scale (DASS 21)

    immediately after the last interview

  • Dispositional Hope Scale

    immediately after the last interview

Study Arms (2)

hope-focused motivational interview-experimental group

ACTIVE COMPARATOR

* Volunteering to participate in research * Being over the age of 18 * Being able to read and write

Other: hope-focused motivational interview

control group

NO INTERVENTION

* Volunteering to participate in research * Being over the age of 18 * Being able to read and write

Interventions

The eight-week hope-focused motivational interview will be applied to each individual individually during dialysis treatment. Within the scope of the study, a hope tree will be created for each individual together with the patients to be used in the evaluation process of the interview sessions. Through the hope tree, it is aimed for the individual to set goals, to discover the obstacles and solutions in achieving these goals.

hope-focused motivational interview-experimental group

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in research
  • Being over the age of 18
  • Being able to read and write

You may not qualify if:

  • Not attending the interview for more than 2 weeks,
  • Development of a medical condition that prevents interviews,
  • Exercising the participant's right to withdraw from the trial at his / her own request.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (2)

  • Samavi SA, Najarpourian S, Javdan M. The Effectiveness of Group Hope Therapy in Labor Pain and Mental Health of Pregnant Women. Psychol Rep. 2019 Dec;122(6):2063-2073. doi: 10.1177/0033294118798625. Epub 2018 Sep 11. No abstract available.

    PMID: 30205789BACKGROUND
  • Rahimipour M, Shahgholian N, Yazdani M. Effect of hope therapy on depression, anxiety, and stress among the patients undergoing hemodialysis. Iran J Nurs Midwifery Res. 2015 Nov-Dec;20(6):694-9. doi: 10.4103/1735-9066.170007.

    PMID: 26793255BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • İLKAY KESER

    i.keser@akdeniz.edu.tr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Pre-test will be applied to all individuals determined according to the inclusion and exclusion criteria. After the pre-test application, the envelope method will be used to determine the individuals who will form the experimental and control groups. 1 for the experimental group in 22 envelopes and 2 for the control group in the other 22 envelopes and all of them will be stored in a box. After each patient pulls the envelope, their group will be determined and the envelope will not be thrown back into the box. The researcher who will apply the intervention and evaluate the data in this planned study is the same person. It will be ensured that only the individuals involved in the research do not learn the group they are in, and one-way blinding will be made.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled, pretest-posttest control group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

After the research was completed, it was deemed appropriate to share.

Locations