University StudentsNCT06814613
The Effect of Progressive Relaxation Exercises on the Sleep Quality of Nursing Students
A study testing Exercise in people with University Students, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The study aims to examine the effect of progressive relaxation exercises administered to nursing students via telenursing on sleep quality after the February 6 earthquake in Turkey. Materials and Methods: The study was conducted as a randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- University Students
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Mar 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study included students who were in one of the 11 cities affected by the Turkey earthquake,
- did not have a medical diagnosis related to sleep disorders,
- were not using any sleep medications or long-acting treatments,
- had access to necessary equipment for telenursing such as the internet, computer, or phone,
- were enrolled in the first, second, or third year of the nursing program.
Who cannot join
- The fourth-grade nursing students were excluded from the study because they undergo internship training and work night shifts,
- which may affect their sleep patterns and quality and create a difference between them and other students.
- Students with any diagnosis related to sleep and those with any psychiatric diagnosis were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progressive Relaxation Exercises Administered Via Telenursing on the Sleep Quality of Nursing Students After the Earthquake in Turkey
Aim: The study aims to examine the effect of progressive relaxation exercises administered to nursing students via telenursing on sleep quality after the February 6 earthquake in Turkey.
Materials and Methods: The study was conducted as a randomized controlled study. The study population consisted of first-, second-, and third-year nursing students enrolled in the nursing departments of two universities located in eastern Turkey, who were residing in one of the 11 cities affected by the earthquake during the February 6 Turkey earthquake. The sample included 86 students (40 experimental, 46 control). While the control group received no intervention, the experimental group received progressive relaxation exercises for 20 minutes every night for 4 weeks, 1 hour before the routine bedtime (or the time they planned to go to sleep) by making a video call (via Google Meet application) with the student. Data were collected using a personal information form and the Pittsburgh Sleep Quality Scale. Descriptive statistical methods (frequency, percentage, arithmetic mean, standard deviation), independent groups t-test, and paired t-test were used to evaluate the data.
Conclusion: The research results can showed that progressive relaxation exercises could be an effective intervention in improving sleep quality after an earthquake. Additionally, conducting these exercises via telenursing could contribute significantly to the sustainability and control of the intervention.
Read the detailed description
- If the students have any pre-sleep habits (using aromatic oil, massage, listening to music, etc.) that they routinely practice and that may affect the results of the study, they will be asked not to do so for 6 weeks.
- A video call is made with the students.
- The procedure is explained to the patient and any questions are answered or concerns are addressed.
- If possible, the patient is asked to move to a ventilated room away from noise so that the procedure can be performed comfortably and not interrupted.
- Procedure
- It is explained to the individual that the procedure can be done sitting or lying down and he/she is asked to release his/her muscles and take a comfortable position.
- The individual is asked to close his/her eyes and focus only on his/her body.
- For 5 seconds, the individual is asked to take a slow deep breath.
- He/she is asked to breathe out in a controlled manner in 3-4 seconds.
- The process of taking a deep breath in 5 seconds and giving it back in 3-4 seconds is repeated 3 times.
- While breathing, the individual is asked to squeeze his/her forehead muscles by raising his/her eyebrows as high as possible at the same time.
- After 10 seconds of tightening the forehead muscles, the patient is asked to slowly lower his/her eyebrows and slowly relax and release the forehead muscles while exhaling. He/she is encouraged to feel the relaxation in the forehead muscles.
- The individual is asked to take a deep breath, close his/her eyes tightly and squeeze the muscles around the eyes.
- After 10 seconds of tightening the muscles around the eyes, he/she is asked to slowly relax and release the muscles around the eyes while exhaling. With muscle
- Conditions
- University Students
- Being tested
- Exercise
- Keywords
- Earthquake, Nursing students, Progressive relaxation exercises, Sleep, Telenursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Progressive relaxation exercises practice
For the next 4 weeks, every night, 1 hour before the routine bedtime (or the time when the student planned to sleep), a video call (via the Google Meet application) was made with the student, and progressive relaxation exercises were performed. The exercise took approximately 20 minutes and followed the implementation protocol (Davis et al., 2008; Payne, 2000). Group interviews were conducted for students with similar sleep hours. They were asked to move to a ventilated room away from noise so that the exercises could be practiced comfortably and not interrupted.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Progressive relaxation exercises were conducted by the researcher, who had received training in this area. The students were informed in detail about the study's implementation process.
For the next 4 weeks, every night, 1 hour before the routine bedtime (or the time when the student planned to sleep), a video call (via the Google Meet application) was made with the student, and progressive relaxation exercises were performed. The exercise took approximately 20 minutes and followed the implementation protocol (Davis et al., 2008; Payne, 2000). Group interviews were conducted for students with similar sleep hours. They were asked to move to a ventilated room away from noise so that the exercises could be practiced comfortably and not interrupted. Receives: Other: Exercise |
| control | No intervention | No intervention was applied to the control group in the study. Data collection forms were filled out only at the beginning and in the fourth week of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index The scale was developed by Buysse et al. and validated in Turkish by Agargün et al. (Buysse et al., 1989; Agargün, 1996). Of the 24 items on the scale, 18 are included in the evaluation. The scale consists of 7 sub-dimensions: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficacy, Sleep Disturbances, Use of Sleep Medication, and Daytime Dysfunction. Each sub-dimension is scored between 0-3, and the total scale score ranges from 0 to 21. An increase in the scale score indicates a decline in sleep quality. The results are evaluated in three categories: 0-5 points indicate healthy sleep, 6-10 points indicate poor sleep, and above 10 points indicate chronic sleep disturbance. The Cronbach's alpha internal consistency coefficient for the scale was calculated as 0.80 by Ağargün (1996).
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Dec 2023
- Primary completion15 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for University StudentsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized controlled experimental model
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher ÇEVİK, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814613
- Sponsor's protocol ID
- seher CEVİK AKTURA
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' data were collected for research purposes only according to the ethical principle of condentiality and protection. Therefore, it cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises Administered Via Telenursing on the Sleep Quality of Nursing Students After the Earthquake in Turkey
- ClinicalTrials.gov ID
- NCT06814613
- Acronym / sponsor ID
- seher CEVİK AKTURA
- Conditions
- University Students
- Keywords
- Earthquake, Nursing students, Progressive relaxation exercises, Sleep, Telenursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 7 Feb 2025 (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: The study aims to examine the effect of progressive relaxation exercises administered to nursing students via telenursing on sleep quality after the February 6 earthquake in Turkey.
Materials and Methods: The study was conducted as a randomized controlled study. The study population consisted of first-, second-, and third-year nursing students enrolled in the nursing departments of two universities located in eastern Turkey, who were residing in one of the 11 cities affected by the earthquake during the February 6 Turkey earthquake. The sample included 86 students (40 experimental, 46 control). While the control group received no intervention, the experimental group received progressive relaxation exercises for 20 minutes every night for 4 weeks, 1 hour before the routine bedtime (or the time they planned to go to sleep) by making a video call (via Google Meet application) with the student. Data were collected using a personal information form and the Pittsburgh Sleep Quality Scale. Descriptive statistical methods (frequency, percentage, arithmetic mean, standard deviation), independent groups t-test, and paired t-test were used to evaluate the data.
Conclusion: The research results can showed that progressive relaxation exercises could be an effective intervention in improving sleep quality after an earthquake. Additionally, conducting these exercises via telenursing could contribute significantly to the sustainability and control of the intervention.
Detailed description
- If the students have any pre-sleep habits (using aromatic oil, massage, listening to music, etc.) that they routinely practice and that may affect the results of the study, they will be asked not to do so for 6 weeks.
- A video call is made with the students.
- The procedure is explained to the patient and any questions are answered or concerns are addressed.
- If possible, the patient is asked to move to a ventilated room away from noise so that the procedure can be performed comfortably and not interrupted.
- Procedure
- It is explained to the individual that the procedure can be done sitting or lying down and he/she is asked to release his/her muscles and take a comfortable position.
- The individual is asked to close his/her eyes and focus only on his/her body.
- For 5 seconds, the individual is asked to take a slow deep breath.
- He/she is asked to breathe out in a controlled manner in 3-4 seconds.
- The process of taking a deep breath in 5 seconds and giving it back in 3-4 seconds is repeated 3 times.
- While breathing, the individual is asked to squeeze his/her forehead muscles by raising his/her eyebrows as high as possible at the same time.
- After 10 seconds of tightening the forehead muscles, the patient is asked to slowly lower his/her eyebrows and slowly relax and release the forehead muscles while exhaling. He/she is encouraged to feel the relaxation in the forehead muscles.
- The individual is asked to take a deep breath, close his/her eyes tightly and squeeze the muscles around the eyes.
- After 10 seconds of tightening the muscles around the eyes, he/she is asked to slowly relax and release the muscles around the eyes while exhaling. With muscle
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled experimental model
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: ExerciseProgressive relaxation exercises were conducted by the researcher, who had received training in this area. The students were informed in detail about the study's implementation process. For the next 4 weeks, every night, 1 hour before the routine bedtime (or the time when the student planned to sleep), a video call (via the Google Meet application) was made with the student, and progressive relaxation exercises were performed. The exercise took approximately 20 minutes and followed the implementation protocol (Davis et al., 2008; Payne, 2000). Group interviews were conducted for students with similar sleep hours. They were asked to move to a ventilated room away from noise so that the exercises could be practiced comfortably and not interrupted. |
| control | No intervention | –No intervention was applied to the control group in the study. Data collection forms were filled out only at the beginning and in the fourth week of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The study included students who were in one of the 11 cities affected by the Turkey earthquake,
- did not have a medical diagnosis related to sleep disorders,
- were not using any sleep medications or long-acting treatments,
- had access to necessary equipment for telenursing such as the internet, computer, or phone,
- were enrolled in the first, second, or third year of the nursing program.
Key exclusion criteria (3 listed)
- The fourth-grade nursing students were excluded from the study because they undergo internship training and work night shifts,
- which may affect their sleep patterns and quality and create a difference between them and other students.
- Students with any diagnosis related to sleep and those with any psychiatric diagnosis were also excluded.
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 |
|---|---|---|
| ExerciseAlso: Progressive relaxation exercises practiceFor the next 4 weeks, every night, 1 hour before the routine bedtime (or the time when the student planned to sleep), a video call (via the Google Meet application) was made with the student, and progressive relaxation exercises were performed. The exercise took approximately 20 minutes and followed the implementation protocol (Davis et al., 2008; Payne, 2000). Group interviews were conducted for students with similar sleep hours. They were asked to move to a ventilated room away from noise so that the exercises could be practiced comfortably and not interrupted. | Other | Intervention |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 3 month
Pittsburgh Sleep Quality Index The scale was developed by Buysse et al. and validated in Turkish by Agargün et al. (Buysse et al., 1989; Agargün, 1996). Of the 24 items on the scale, 18 are included in the evaluation. The scale consists of 7 sub-dimensions: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficacy, Sleep Disturbances, Use of Sleep Medication, and Daytime Dysfunction. Each sub-dimension is scored between 0-3, and the total scale score ranges from 0 to 21. An increase in the scale score indicates a decline in sleep quality. The results are evaluated in three categories: 0-5 points indicate healthy sleep, 6-10 points indicate poor sleep, and above 10 points indicate chronic sleep disturbance. The Cronbach's alpha internal consistency coefficient for the scale was calculated as 0.80 by Ağargün (1996).
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 7 Feb 2025.
- Individual participant dataSharing planned: No. Participants' data were collected for research purposes only according to the ethical principle of condentiality and protection. Therefore, it cannot be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with University Students, run by Inonu University at 1 site in Turkey (Türkiye).
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 3 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 7 Feb 2025. 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 Turkey (Türkiye). 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?
Pittsburgh Sleep Quality Index (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2025.