Quality of SleepNCT03224676
Study to Assess the Quality of Sleep and Perceived Sleep Distractors Among the Adult Patients Admitted in Selected Hospital
An observational study of Quality of Sleep, run by Maharishi Markendeswar University (Deemed to be University).
Trial summary
Aim of the study was to assess the quality of sleep among adult patients, to explore the perceived sleep distractors among adult patients, to determine the relationship between quality of sleep and perceived sleep distractors score among adult patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Quality of Sleep
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2015to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- The study includes adult patients who were:
- between age group of 18-65 years
- hospitalized minimum for 7 days.
- willing to participate in the study.
- present at the time of data collection.
Who cannot join
- alert and oriented.
About this study
Aim of the study was to assess the quality of sleep among adult patients, to explore the perceived sleep distractors among adult patients, to determine the relationship between quality of sleep and perceived sleep distractors score among adult patients.
and to determine the association of quality of sleep and perceived sleep distractors score among adult patients with selected variables.
Read the detailed description
A total of 150 adult patients were selected from surgical, orthopedic and medical wards to participate in the study 50 patients from each ward. All the adult patients were selected using convenience sampling technique. Self-introduction and establishing rapport with the subjects was done. Purpose of the study was explained to the subjects, the confidentially of their responses was assured, and informed consent was taken prior to the study. The data was collected by Modified Pittsburgh Sleep Quality Index and Structured Perceived Sleep Distractors Performa.
- Conditions
- Quality of Sleep
- Keywords
- Quality of sleep, Perceived sleep distractors, Adult patients
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sleep
It comprised of total 7 components. Each item is rated as 0, 1, 2, 3. The maximum possible score was 21 and minimum possible score was zero on the Modified Pittsburgh sleep Questionnaire
Measured: 20-25 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start30 Nov 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, priti sirohi, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Preeti Sirohi, Msc.Nursing, Principal investigator, Maharishi Markandeshwar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224676
- Sponsor's protocol ID
- IEC/P.N786
- Status last verified
- Jul 2017
- First submitted
- 19 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levenson JC, Shensa A, Sidani JE, Colditz JB, Primack BA. The association between social media use and sleep disturbance among young adults. Prev Med. 2016 Apr;85:36-41. doi: 10.1016/j.ypmed.2016.01.001. Epub 2016 Jan 11.
PubMed 26791323van Leeuwen WM, Lehto M, Karisola P, Lindholm H, Luukkonen R, Sallinen M, Harma M, Porkka-Heiskanen T, Alenius H. Sleep restriction increases the risk of developing cardiovascular diseases by augmenting proinflammatory responses through IL-17 and CRP. PLoS One. 2009;4(2):e4589. doi: 10.1371/journal.pone.0004589. Epub 2009 Feb 25.
PubMed 19240794Shim J, Kang SW. Behavioral Factors Related to Sleep Quality and Duration in Adults. J Lifestyle Med. 2017 Jan;7(1):18-26. doi: 10.15280/jlm.2017.7.1.18. Epub 2017 Jan 31.
PubMed 28261557
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Quality of Sleep and Perceived Sleep Distractors Among the Adult Patients Admitted in Selected Hospital
- ClinicalTrials.gov ID
- NCT03224676
- Acronym / sponsor ID
- IEC/P.N786
- Conditions
- Quality of Sleep
- Keywords
- Quality of sleep, Perceived sleep distractors, Adult patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the study was to assess the quality of sleep among adult patients, to explore the perceived sleep distractors among adult patients, to determine the relationship between quality of sleep and perceived sleep distractors score among adult patients.
and to determine the association of quality of sleep and perceived sleep distractors score among adult patients with selected variables.
Detailed description
A total of 150 adult patients were selected from surgical, orthopedic and medical wards to participate in the study 50 patients from each ward. All the adult patients were selected using convenience sampling technique. Self-introduction and establishing rapport with the subjects was done. Purpose of the study was explained to the subjects, the confidentially of their responses was assured, and informed consent was taken prior to the study. The data was collected by Modified Pittsburgh Sleep Quality Index and Structured Perceived Sleep Distractors Performa.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between age group of 18-65 years
- hospitalized minimum for 7 days.
- willing to participate in the study.
- present at the time of data collection.
Key exclusion criteria (1 listed)
- alert and oriented.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of sleep
Time frame: 20-25 min.
It comprised of total 7 components. Each item is rated as 0, 1, 2, 3. The maximum possible score was 21 and minimum possible score was zero on the Modified Pittsburgh sleep Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 26791323Levenson JC, Shensa A, Sidani JE, Colditz JB, Primack BA. The association between social media use and sleep disturbance among young adults. Prev Med. 2016 Apr;85:36-41. doi: 10.1016/j.ypmed.2016.01.001. Epub 2016 Jan 11.
- Background: PubMed 19240794van Leeuwen WM, Lehto M, Karisola P, Lindholm H, Luukkonen R, Sallinen M, Harma M, Porkka-Heiskanen T, Alenius H. Sleep restriction increases the risk of developing cardiovascular diseases by augmenting proinflammatory responses through IL-17 and CRP. PLoS One. 2009;4(2):e4589. doi: 10.1371/journal.pone.0004589. Epub 2009 Feb 25.
- Background: PubMed 28261557Shim J, Kang SW. Behavioral Factors Related to Sleep Quality and Duration in Adults. J Lifestyle Med. 2017 Jan;7(1):18-26. doi: 10.15280/jlm.2017.7.1.18. Epub 2017 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preeti Sirohi, Msc.Nursing principal investigator
Maharishi Markandeshwar University
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Sleep, run by Maharishi Markendeswar University (Deemed to be University).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of sleep (time frame: 20-25 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224676, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.