| CTRI Number |
CTRI/2024/09/073503 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to check the quality of sleep among patients admitted in orthopaedic ward after surgery |
|
Scientific Title of Study
|
Sleep Quality and the Factors Influencing Sleep Among Post-Operative In-Patients in
Orthopaedic Unit; Findings of a Cross-sectional Design |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gowri P |
| Designation |
Post graduate student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
room no PT05
5th floor
SRM College of Physiotherapy
SRM Institute of Science and Technology
SRM nagar Potheri
Kattankulathur
Chennai Tamilnadu
India
Chennai
TAMIL NADU
603203
India |
| Phone |
8825521992 |
| Fax |
|
| Email |
gowripugazh.ngpl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balamurugan Janakiraman |
| Designation |
Research Associate |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no PT29 4th floor
SRM college of physiotherapy SRM Institute of Science and Technologyy
SRM nagar Kattankulathur Chennai TamilNadu
India
Chennai
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balamurugan Janakiraman |
| Designation |
Research Associate |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room no PT29 4th floor
SRM college of physiotherapy SRM Institute of Science and Technologyy
SRM nagar Kattankulathur Chennai TamilNadu
India
Chennai
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology |
|
|
Primary Sponsor
|
| Name |
SRM College of Physiotherapy SRM Institute of Science and Technology |
| Address |
Room no PT05
5th floor
SRM college of physiotherapy
SRM Institute of Science and Technology
SRM nagar Potheri
Kattankulathur
Chennai
Tamilnadu 603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Gowri Pugazh |
SRM Medical College Hospital and Research Centre |
Orthopedic ward second floor
SRM Medical College Hospital and Research Centre
SRM nagar Potheri
Kattankulathur
Chennai
Tamilnadu 603203
Chennai
TAMIL NADU |
8825521992
gowripugazh.ngpl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T14-T14||Injury of unspecified body region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Aged 15 or above
Both Genders
In-patients in orthopedic unit of SRMIST
Length of stay for more than 2 days consisted of 2 night cycle
Patients able to read speak and talk the regional language Tamil
|
|
| ExclusionCriteria |
| Details |
Cognitive impairment
Known conditions and treated for sleep disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Semi structured questionnaire
Sleep Quality Among Postoperative Orthopedic patients |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh Sleep Quality Index |
baseline |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PURPOSE OF THE STUDY
To determine the
quality of sleep and the predictors among post operative in-patients in the
orthopaedic ward.
THE RESEARCH
QUESTIONS;
- How to quantify the quality of sleep among in-patients in
orthopedic post-op unit?
- Does the quantifiable sleep parameters relate to factors like age,
gender, pain, sleep hygiene, and environmental factors?
- Is it possible to identify the models for sleep predictors,
moderators, and mediators using regression models?
EXPECTED RESULTS
• The study is expected to reveal the insights of the
sleep quality of post-operative in-patients in the orthopedic unit and also
identify the factors influencing their sleep.
• Understanding these aspects can contribute to develop
strategies to improve quality of sleep and their overall recovery.
DISCUSSION
The study aims to determine the quality of sleep and
factors influencing sleep among post-operative in-patients in the Orthopaedic
ward. This study plays a crucial exploration of the often-overlooked aspect of
patient recovery. Understanding and improving sleep quality can significantly
impact the overall well-being and recovery of post-operative orthopedic in-patients.
Postoperative pain is a common concern for orthopedic patients, and its impact
on sleep can be profound. Exploring strategies to manage pain effectively
without compromising sleep is essential for improving the overall patient
experience.
Additionally, environmental factors within the
orthopedic ward may contribute to disrupted sleep. Noise levels, lighting
conditions, and the general hospital setting can all play a role. Identifying
and addressing these factors could lead to interventions that create a more
conducive sleep environment for postoperative inpatients. Furthermore, the
psychological and emotional state of patients post-surgery may affect their
ability to sleep. Anxiety, stress, and other emotional factors can contribute
to sleep disturbances. Incorporating mental health support and coping
mechanisms into the postoperative care plan may positively impact sleep
quality.
Considering the diverse demographic of orthopedic
patients, exploring potential variations in sleep patterns based on age,
gender, or pre-existing conditions could provide valuable insights. Tailoring
interventions to specific patient profiles can enhance the effectiveness of
sleep improvement strategies. By
understanding the multifaceted nature of sleep quality and the factors
influencing it, healthcare providers can develop targeted interventions to
promote better sleep and, consequently, improved recovery outcomes for post-operative
orthopedic in-patients. |