NCT06175585

Brief Summary

The impact of narrative nursing interventions on negative emotions, self-efficacy, quality of life in individuals undergoing maintenance hemodialysis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2024

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 4, 2023

Last Update Submit

December 17, 2023

Conditions

Keywords

self-efficacynegative emotionslife quality

Outcome Measures

Primary Outcomes (2)

  • Zung's Self-Rating Anxiety Scale

    assess the anxiety and depression levels of patients

    one week

  • Self-rating Depression Scale

    assess the anxiety and depression levels of patients

    one week

Study Arms (2)

traditional nursing group

Other: traditional nursing

narrative nursing group

Other: narrative nursing

Interventions

The narrative nursing process is based on the practice of "two-line system" proposed by Jiang, which is carried out in a separate classroom, office or ward with sufficient space and good lighting. The environment is set to the right temperature and humidity for comfortable face-to-face conversation. This process is done in stages, depending on how often the patient is dialysis three or more times a week. Each session lasts about 30 minutes and the whole process lasts four weeks. Adjust to the specific needs of each patient .

narrative nursing group

Patients undergoing MHD received traditional nursing interventions, encompassing various aspects such as dietary advice, instructions on medication usage, health education, emphasis on precautions during dialysis, and guidelines for vascular access care. Additionally, the nurses proactively inquired about patients' emotional well-being during the nursing shift change, actively engaged and uplifted patients experiencing low spirits, and encouraged family members to provide emotional support.

traditional nursing group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing MHD at the Department of Nephrology in our hospital.

You may qualify if:

  • Patients diagnosed with ESRD and treated with dialysis for more than 3 months;
  • Patients aged ≥18 years old;
  • Patients with complete clinical data;
  • Patients who are clearly conscious and can accurately express their willingness;
  • Patients who have signed informed consent and are willing to cooperate with the study.

You may not qualify if:

  • Patients with other serious systemic diseases, such as severe cardiovascular and cerebrovascular diseases, severe diabetes, etc.;
  • Patients with mental disorder, such as cognitive or intellectual disability;
  • Patients with a history of anxiety and depression;
  • Patients with intermittent loss of consciousness or are unable to understand the questions in the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jie Zheng, Associate professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 19, 2023

Study Start

November 29, 2023

Primary Completion

November 29, 2024

Study Completion

December 29, 2024

Last Updated

December 19, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Locations