| CTRI Number |
CTRI/2022/08/044974 [Registered on: 26/08/2022] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of nursing care on weight gain, feeling of worry, helplessness and well-being of chronic kidney patients |
|
Scientific Title of Study
|
The effect of multidisciplinary nursing intervention on interdialytic weight gain, anxiety and depression and quality of life among chronic heamodialysis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmimala Pradhan |
| Designation |
Associate Professor |
| Affiliation |
SUM NURSING COLLEGE |
| Address |
Medical Surgical Departemnt, 2nd floor, room no-3, K-8, KALINGA NAGAR, GHATIKIA, BHUBANESWAR-751003, ODISHA
K-8, KALINGA NAGAR, GHATIKIA, BHUBANESWAR-751003, ODISHA
Khordha
ORISSA
751003
India |
| Phone |
|
| Fax |
|
| Email |
rashmimalapradhan@soa.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashmimala Pradhan |
| Designation |
Associate Professor |
| Affiliation |
SUM NURSING COLLEGE |
| Address |
Medical Surgical Nursing, 2nd floor, room no-3, K-8, KALINGA NAGAR, GHATIKIA, BHUBANESWAR-751003, ODISHA
K-8, KALINGA NAGAR, GHATIKIA, BHUBANESWAR-751003, ODISHA
Khordha
ORISSA
751003
India |
| Phone |
|
| Fax |
|
| Email |
rashmimalapradhan@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pravati Tripathy |
| Designation |
Dean |
| Affiliation |
SUM NURSING COLLEGE |
| Address |
Deans Room, Ground Floor, K-8, KALINGA NAGAR, GHATIKIA, BHUBANESWAR-751003, ODISHA
K-8, KALINGA NAGAR, GHATIKIA, BHUBANESWAR-751003, ODISHA
Khordha
ORISSA
751003
India |
| Phone |
|
| Fax |
|
| Email |
dean.snc@soa.ac.in |
|
|
Source of Monetary or Material Support
|
| Self - financing (Not Support from other sources) |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
K-8, Kalinga nagar, Ghatikia, Bhubaneswar-751003 |
| Type of Sponsor |
Other [Not Applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Debaprasad Kar |
IMS & SUM Hospital |
Nephrology Department, Dialysis Unit, 1st Floor, Room No-1, k-8, Kalinga Nagar, Ghatikia, Bhubaneswar-751003
Khordha
ORISSA |
7080185569
debaprasadkar@soa.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, IMS & SUM Hospital, SOA (Deemed to be University)e |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Routine care in between two consecutive dialysis session |
| Intervention |
Multidisciplinary Nursing Intervention |
Session 1
Introducing the research assistant, the objectives,
and content of the sessions, the Hospital Anxiety
and Depression Scale (HADS) and KDQOL TM 36, the
demographic and clinical information to be
completed by the research assistant
Session 2
Promoting knowledge by understanding the
symptoms, risk factors, stages of kidney disease and
complications of haemodialysis (PPT)
Session 3
Home-based care and management of haemodialysis complications
(such as diet and nutrition,(Leaflet), weight control (Fluid distribution
timetable), medication, and available resources)
Session 4
Fistula care and hygiene (skin) care(demonstration)
Session 5
Lifestyle Change, Emotional Support, Manage Mental Health and
physical health in haemodialysis patients (educational and
motivational talk)
Session 6
A review of the discussed points, receiving feedback from the
members regarding the discussed points, question and answer, group
discussion, and completing the, HADS and KDQOL.TM 36 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Chronic kidney patients on
haemodialysis who were
Continuing their maintenance haemodialysis for a
period of three months and above on an outdoor basis
Age ≥ 18 years to 65 years
Able to read, communicate and understand Odia,
Hindi and English
Able to carry out the instruction
Willing to be included in the study |
|
| ExclusionCriteria |
| Details |
Chronic kidney patients on haemodialysis who were
Continuing their haemodialysis on an indoor basis
Patients who required full support for ambulation
Patients who were not cooperative and not interested
to participate
Who was diagnosed or on the treatment of any of the
mental illness or on psychotherapy
Who had a vision problem |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the effect of multidisciplinary nursing
intervention on interdialytic weight gain, anxiety and
depression and quality of life among chronic haemodialysis
patients in a selected tertiary care hospital |
base line 6 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the level of interdialytic weight gain, anxiety
and depression and quality of life among chronic
haemodialysis patients in a selected tertiary care hospital
|
base line, 6 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="133"
Sample Size from India="133"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2022 |
| Date of Study Completion (India) |
28/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Title: Effect of multidisciplinary nursing intervention on interdialytic weight gain and quality of life among chronic hemodialysis patients: A randomized controlled trial
Journal: Journal of Integrative Nursing
Date of Publication: Jan-Mar 2025
DOI: 10.4103/jin.jin_6_25
Other variables- Manuscript submitted to [BMC Nephrology, BMC Nursing] and currently under peer review. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This randomized controlled trial was conducted to evaluate the effect of multidisciplinary nursing intervention on interdialytic weight gain (IDWG), anxiety, depression, and quality of life among chronic haemodialysis patients. A total of 132 patients undergoing maintenance haemodialysis at IMS & SUM Hospital, Bhubaneswar, Odisha, India, were initially enrolled between February 2023 and February 2024; of these, 120 participants continued and completed the study. Participants were randomly assigned into an experimental group (n=65) and a control group (n=55) using block randomization. The experimental group received structured multidisciplinary nursing interventions—including individualized dietary planning, fluid management education, psychological support, and lifestyle guidance—alongside standard treatment for six weeks. The control group received only standard care during the study period and was given dietary and fluid guidance after study completion. The results showed statistically significant improvements in the experimental group, with a marked reduction in interdialytic weight gain (F=20.05, p<0.001), anxiety (from 12.37 ± 1.57 to 10.6 ± 1.05), and depression scores (from 11.92 ± 1.41 to 10.38 ± 1.23). The quality of life, measured by KDQOLTM 36 scores, improved from 49.38 ± 9.56 to 58.63 ± 6.04 in the experimental group, compared to a smaller increase in the control group. The study concluded that multidisciplinary nursing interventions significantly improved clinical and psychological outcomes in chronic haemodialysis patients, demonstrating its effectiveness as a supportive care strategy. |