SleepNCT05273086
The Effect of a Sleep Intervention on Sleep Quality in Nursing Students
A study testing Sleep Intervention Group in people with Sleep and Healthy Lifestyle, run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
The sleep quality in university students is diminished by numerous factors such as alterations in lifestyles, changes, the socio-emotional development or academic performance.The detriment in the quality of sleep can have a negative effects on the quality of life and mental health. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Healthy Lifestyle
- What is being tested?
- Sleep Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2022to 30 Apr 2023
- Phase
- Interventional
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students between 18 and 25 years old.
- Students enrolled in the first full Nursing course at Camilo Jose Cela University 2022-23
Who cannot join
- Previous diagnosis of mental pathology and/or sleep disorders without or with medication (hypnotics, sedatives and melatonin).
- Work activity simultaneous to academic training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Sleep Intervention on Sleep Quality in Nursing Students: Study Protocol for a Pilot Randomised Controlled Trial
The sleep quality in university students is diminished by numerous factors such as alterations in lifestyles, changes, the socio-emotional development or academic performance.The detriment in the quality of sleep can have a negative effects on the quality of life and mental health. It is even a risk factor for cardiovascular diseases. This study is a pilot type clinical trial in which it is intended to implement an intervention to improve the quality of sleep of university nursing students. A randomization of 40 students will be carried out to two treatment groups (intervention n=20 and control n=20). The intervention group will receive two 90-minute sessions during a week where the anatomical structures involved in sleep will be analyzed, workshops will be held to improve the quality of sleep with individual indications after analyzing their rhythms and patterns. The control group will continue with their usual routine.A pre-post evaluation will be carried out on both groups using the Kronowise 3.0 individual wearable bracelet device that measures sleep quality based on general indicators, sleep, wakefulness, internal time, circadian rhythms, temperature, activity, position and light. In addition, information on perceived sleep quality will be collected with the Pittsburgh questionnaire. Sociodemographic data will be collected in the pre measurement for both groups and satisfaction with the program will be collected in the post measurement in the intervention group.
Read the detailed description
The program consists of 2 sessions of 90 minutes during one week. In the first session, four activities will be carried out: 1) Explanation of the concepts of chronobiology, biological rhythms of the human being, internal clock and synchronizer, and the importance of anatomical structures; 2) Location of the structures mentioned in diagrams and anatomical models of the nervous system; 3) Approach to the concept of chronotype and the existence of three times that affect human circadian rhythms (biological, artificial and social), and how a poor coupling between them leads to a state called chronodisruption; 4) Completion of 2 self-knowledge questionnaires about the sleep pattern. The second session will also consist of four activities: 1) Recommendations on skills to have optimal sleep quality; 2) Carrying out a questionnaire on daytime sleepiness; 3) Applications of the recommendations to the nursing field (work shifts, clinical application in patients); Delivery of the reports to the participants, resolution of questions related to them, and group analysis of the reports of patients with certain circadian pathologies.
- Conditions
- Sleep, Healthy Lifestyle
- Being tested
- Sleep Intervention Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Intervention GroupBehavioural
The intervention group will acquire skills to improve their quality of sleep such as:
- Acquisition of notions of chronobiology.
- Location of the nervous structures involved in biological rhythms.
- Awareness of the existence of three times that direct our biological rhythms, and of the need for them to be synchronized.
- Self-knowledge of the chronotype and the degree of adjustment of the three times.
- Knowledge of the variables that determine a good quality of sleep.
- Applications of chronobiology to the field of nursing. Recommendations for nurses and patients.
- Self-knowledge of the quality of sleep and the health status of the circadian system.
| Study group | Role | What they receive |
|---|---|---|
| Sleep intervention program | Experimental | The Sleep Intervention program Group will be subdivided into two groups of 10 participants to receive the sleep quality improvement program. The program consists of 2 sessions of 90 minutes during one week. Receives: Behavioral: Sleep Intervention Group |
| Control Group | No intervention | The control group will continue with their usual routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline sleep quality at after intervention. Number of participants who improve their quality of sleep after the intervention evaluated by Kronowise 3.0.
Kronowise 3.0 wearable wristband individual device. Participants wear the bracelet for 24 hours, 7 days in a row, including weekdays and weekends. Kronowise 3.0 is a multichannel device that continuously records the rhythms of Body Temperature of the skin, Activity (intensity, duration and time), Body Position and light exposure (intensity, type of light, duration and time). All these parameters are registered and combined in a report that indicates the degree of quality of the person's sleep as good, fair or poor. This device is validated as an objective measure of sleep quality equivalent to polysomnography.
Measured: Baseline (before starting the intervention) and post-intervention (3 weeks)
Change from baseline perceived sleep quality at after intervention. The Pittsburgh Sleep Quality Index (PSQI) is a vañidated tool that measures the perceived sleep quality.
The Pittsburgh Sleep Quality Index (PSQI) is a self-assessed questionnaire that measures sleep quality and disturbances over a 1-month time interval. It consists of 19 self-assessed items that are combined into 7 components for a total score of 0 to 21 points (0 indicates good sleep quality and up to 21 points indicates poor quality). The questionnaire has an internal consistency coefficient of 0.81 in the Spanish population.
Measured: Baseline (before starting the intervention) and post-intervention (3 weeks)
Secondary outcomes (8)
Date of birth data. Questionnaire developed by researchers.
Date of birth
Measured: Baseline (before starting the intervention)
Toxic habits. Questionnaire developed by researchers.
Data of doses per day regarding the consumption of tobacco, alcohol and drugs.
Measured: Baseline (before starting the intervention)
Physical exercise. The International physical activity questionnaire (IPAQ) is a validated tool to measure the exercise practice of individuals per week.
International physical activity questionnaire (IPAQ) will be used to assess physical activity It is composed of 27-item self-reported physical activity measure collects information about home maintenance activities, gardening, occupational, transportation, free time and sedentary activities. Validity with a Cronbach´s alpha of 0.80. The results are classified into exercise activity levels or categories such as: low, moderate or high. The higher the score, the more level of physical activity they have.
Measured: Baseline (before starting the intervention)
Satisfaction with the intervention. Questionnaire developed by researchers.
Participants from the intervention group will be asked about their satisfaction with the program. It will contains information about their opinion regarding its need, and whether they will be able to recommend it to friends or family, using a Likert scale of 0 to 10 developed by researchers, where 0 is nothing and 10 is completely.
Measured: Post-intervention (3 weeks).
Age in years data. Questionnaire developed by researchers.
Age in years
Measured: Baseline (before starting the intervention)
Gender data. Questionnaire developed by researchers.
Gender
Measured: Baseline (before starting the intervention)
Sleep data. Questionnaire developed by researchers.
sleep coexistence during the study (alone or accompanied)
Measured: Baseline (before starting the intervention)
Anthropometric data. Questionnaire developed by researchers.
Body Mass Index (BMI): height and weight
Measured: Baseline (before starting the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start19 Sep 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Pérez Manchón, Dr, Principal investigator, Camilo Jose Cela University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273086
- Sponsor's protocol ID
- Sleep-UCJC
- Status last verified
- Jul 2023
- First submitted
- 3 Feb 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Escobar-Cordoba F, Eslava-Schmalbach J. [Colombian validation of the Pittsburgh Sleep Quality Index]. Rev Neurol. 2005 Feb 1-15;40(3):150-5. Spanish.
PubMed 15750899Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Brown FC, Buboltz WC Jr, Soper B. Development and evaluation of the Sleep Treatment and Education Program for Students (STEPS). J Am Coll Health. 2006 Jan-Feb;54(4):231-7. doi: 10.3200/JACH.54.4.231-237.
PubMed 16450848Blazquez A, Martinez-Nicolas A, Salazar FJ, Rol MA, Madrid JA. Wrist skin temperature, motor activity, and body position as determinants of the circadian pattern of blood pressure. Chronobiol Int. 2012 Jul;29(6):747-56. doi: 10.3109/07420528.2012.679328.
PubMed 22734575Azad MC, Fraser K, Rumana N, Abdullah AF, Shahana N, Hanly PJ, Turin TC. Sleep disturbances among medical students: a global perspective. J Clin Sleep Med. 2015 Jan 15;11(1):69-74. doi: 10.5664/jcsm.4370.
PubMed 25515274Madrid-Navarro CJ, Puertas Cuesta FJ, Escamilla-Sevilla F, Campos M, Ruiz Abellan F, Rol MA, Madrid JA. Validation of a Device for the Ambulatory Monitoring of Sleep Patterns: A Pilot Study on Parkinson's Disease. Front Neurol. 2019 Apr 11;10:356. doi: 10.3389/fneur.2019.00356. eCollection 2019.
PubMed 31031690
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Sleep Intervention on Sleep Quality in Nursing Students: Study Protocol for a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05273086
- Acronym / sponsor ID
- Sleep-UCJC
- Conditions
- Sleep, Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 10 Mar 2022 (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.
The sleep quality in university students is diminished by numerous factors such as alterations in lifestyles, changes, the socio-emotional development or academic performance.The detriment in the quality of sleep can have a negative effects on the quality of life and mental health. It is even a risk factor for cardiovascular diseases. This study is a pilot type clinical trial in which it is intended to implement an intervention to improve the quality of sleep of university nursing students. A randomization of 40 students will be carried out to two treatment groups (intervention n=20 and control n=20). The intervention group will receive two 90-minute sessions during a week where the anatomical structures involved in sleep will be analyzed, workshops will be held to improve the quality of sleep with individual indications after analyzing their rhythms and patterns. The control group will continue with their usual routine.A pre-post evaluation will be carried out on both groups using the Kronowise 3.0 individual wearable bracelet device that measures sleep quality based on general indicators, sleep, wakefulness, internal time, circadian rhythms, temperature, activity, position and light. In addition, information on perceived sleep quality will be collected with the Pittsburgh questionnaire. Sociodemographic data will be collected in the pre measurement for both groups and satisfaction with the program will be collected in the post measurement in the intervention group.
Detailed description
The program consists of 2 sessions of 90 minutes during one week. In the first session, four activities will be carried out: 1) Explanation of the concepts of chronobiology, biological rhythms of the human being, internal clock and synchronizer, and the importance of anatomical structures; 2) Location of the structures mentioned in diagrams and anatomical models of the nervous system; 3) Approach to the concept of chronotype and the existence of three times that affect human circadian rhythms (biological, artificial and social), and how a poor coupling between them leads to a state called chronodisruption; 4) Completion of 2 self-knowledge questionnaires about the sleep pattern. The second session will also consist of four activities: 1) Recommendations on skills to have optimal sleep quality; 2) Carrying out a questionnaire on daytime sleepiness; 3) Applications of the recommendations to the nursing field (work shifts, clinical application in patients); Delivery of the reports to the participants, resolution of questions related to them, and group analysis of the reports of patients with certain circadian pathologies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Sleep intervention program | Experimental | Behavioral: Sleep Intervention GroupThe Sleep Intervention program Group will be subdivided into two groups of 10 participants to receive the sleep quality improvement program. The program consists of 2 sessions of 90 minutes during one week. |
| Control Group | No intervention | –The control group will continue with their usual routine. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Students between 18 and 25 years old.
- Students enrolled in the first full Nursing course at Camilo Jose Cela University 2022-23
Key exclusion criteria (2 listed)
- Previous diagnosis of mental pathology and/or sleep disorders without or with medication (hypnotics, sedatives and melatonin).
- Work activity simultaneous to academic training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Intervention GroupThe intervention group will acquire skills to improve their quality of sleep such as: * Acquisition of notions of chronobiology. * Location of the nervous structures involved in biological rhythms. * Awareness of the existence of three times that direct our biological rhythms, and of the need for them to be synchronized. * Self-knowledge of the chronotype and the degree of adjustment of the three times. * Knowledge of the variables that determine a good quality of sleep. * Applications of chronobiology to the field of nursing. Recommendations for nurses and patients. * Self-knowledge of the quality of sleep and the health status of the circadian system. | Behavioural | Sleep intervention program |
Primary outcome
Change from baseline sleep quality at after intervention. Number of participants who improve their quality of sleep after the intervention evaluated by Kronowise 3.0.
Time frame: Baseline (before starting the intervention) and post-intervention (3 weeks)
Kronowise 3.0 wearable wristband individual device. Participants wear the bracelet for 24 hours, 7 days in a row, including weekdays and weekends. Kronowise 3.0 is a multichannel device that continuously records the rhythms of Body Temperature of the skin, Activity (intensity, duration and time), Body Position and light exposure (intensity, type of light, duration and time). All these parameters are registered and combined in a report that indicates the degree of quality of the person's sleep as good, fair or poor. This device is validated as an objective measure of sleep quality equivalent to polysomnography.
Change from baseline perceived sleep quality at after intervention. The Pittsburgh Sleep Quality Index (PSQI) is a vañidated tool that measures the perceived sleep quality.
Time frame: Baseline (before starting the intervention) and post-intervention (3 weeks)
The Pittsburgh Sleep Quality Index (PSQI) is a self-assessed questionnaire that measures sleep quality and disturbances over a 1-month time interval. It consists of 19 self-assessed items that are combined into 7 components for a total score of 0 to 21 points (0 indicates good sleep quality and up to 21 points indicates poor quality). The questionnaire has an internal consistency coefficient of 0.81 in the Spanish population.
8 secondary outcomes
Date of birth data. Questionnaire developed by researchers.
Time frame: Baseline (before starting the intervention)
Toxic habits. Questionnaire developed by researchers.
Time frame: Baseline (before starting the intervention)
Physical exercise. The International physical activity questionnaire (IPAQ) is a validated tool to measure the exercise practice of individuals per week.
Time frame: Baseline (before starting the intervention)
Satisfaction with the intervention. Questionnaire developed by researchers.
Time frame: Post-intervention (3 weeks).
Age in years data. Questionnaire developed by researchers.
Time frame: Baseline (before starting the intervention)
Gender data. Questionnaire developed by researchers.
Time frame: Baseline (before starting the intervention)
Sleep data. Questionnaire developed by researchers.
Time frame: Baseline (before starting the intervention)
Anthropometric data. Questionnaire developed by researchers.
Time frame: Baseline (before starting the intervention)
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 12 Jul 2023.
- Background: PubMed 15750899Escobar-Cordoba F, Eslava-Schmalbach J. [Colombian validation of the Pittsburgh Sleep Quality Index]. Rev Neurol. 2005 Feb 1-15;40(3):150-5. Spanish.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 16450848Brown FC, Buboltz WC Jr, Soper B. Development and evaluation of the Sleep Treatment and Education Program for Students (STEPS). J Am Coll Health. 2006 Jan-Feb;54(4):231-7. doi: 10.3200/JACH.54.4.231-237.
- Background: PubMed 22734575Blazquez A, Martinez-Nicolas A, Salazar FJ, Rol MA, Madrid JA. Wrist skin temperature, motor activity, and body position as determinants of the circadian pattern of blood pressure. Chronobiol Int. 2012 Jul;29(6):747-56. doi: 10.3109/07420528.2012.679328.
- Background: PubMed 25515274Azad MC, Fraser K, Rumana N, Abdullah AF, Shahana N, Hanly PJ, Turin TC. Sleep disturbances among medical students: a global perspective. J Clin Sleep Med. 2015 Jan 15;11(1):69-74. doi: 10.5664/jcsm.4370.
- Background: PubMed 31031690Madrid-Navarro CJ, Puertas Cuesta FJ, Escamilla-Sevilla F, Campos M, Ruiz Abellan F, Rol MA, Madrid JA. Validation of a Device for the Ambulatory Monitoring of Sleep Patterns: A Pilot Study on Parkinson's Disease. Front Neurol. 2019 Apr 11;10:356. doi: 10.3389/fneur.2019.00356. eCollection 2019.
- 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.
David Pérez Manchón, Dr principal investigator
Camilo Jose Cela University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Intervention Group in people with Sleep and Healthy Lifestyle, run by Camilo Jose Cela University at 1 site in Spain.
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 2 inclusion and 2 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 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline sleep quality at after intervention. Number of participants who improve their quality of sleep after the intervention evaluated by Kronowise 3.0. (time frame: Baseline (before starting the intervention) and post-intervention (3 weeks)). The study lists 2 primary outcomes in all. 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 NCT05273086, which also lists 6 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 12 Jul 2023.