Disc HerniationNCT05687305
The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery
A study testing White Noise in people with Disc Herniation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to determine the effectiveness of listening to white noise on the sleep quality, comfort level, satisfaction level of patients after lumbar disc herniation surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Disc Herniation
- What is being tested?
- White Noise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2022to 30 Jan 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- underwent lumbar disc herniation surgery
- hospitalized for at least 48 hours
- agreed to participate in research
Who cannot join
- chronic sleep problems and taking medication
- Not filling out the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of White Noise on Sleep Quality, Comfort and Satisfaction Level in Patients Undergoing Lumbar Disc Herniation Surgery: A Randomized Controlled Study
The aim of this clinical trial is to determine the effectiveness of listening to white noise on the sleep quality, comfort level, satisfaction level of patients after lumbar disc herniation surgery. The main hypotheses are:
- Is there a difference between the sleep quality of patients who listen to white noise and those who do not?
- Is there a difference between the comfort levels of patients who listen to white noise and those who do not?
- Is there a difference between the satisfaction levels of patients who listen to white noise and those who do not?
The main tasks that the participants will be asked to do will be explained and Their informed consent will be obtained. The two research groups will be compared.
Read the detailed description
This study will be conducted with a total of 60 patients who underwent surgery for lumbar disc herniation at a hospital in Istanbul. Participants in the study who had lumbar disc herniation surgery will be divided into two groups: intervention (n = 30) and control group (n = 30), according to the randomization method created with computer-based random numbers.
On the 0th and 1st postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.Patients in the control group will be monitored according to their routine clinical procedures. Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. Patients in the control group will also be followed up at the same times and with the same forms. Descriptive Characteristics Form, Informed Consent Form, The Richards-Campbell Sleep Questionnaire, General Comfort Questionnaire,Visual Analog Scale for Satisfaction Level will be used in data collection.
- Conditions
- Disc Herniation
- Being tested
- White Noise
- Keywords
- Lumbar Disc Herniation, White Noise, Sleep Quality, Comfort Level
- Medical subject headings
- Intervertebral Disc Displacement, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White NoiseOther
White noise is produced by digitally combining sounds of equal frequency in the laboratory. Then, all of the frequencies in this sound are calibrated to generate noise at each frequency. If the contribution of each region to the noise level is the same, the noise is referred to as white noise. Waterfalls, ocean waves, and wind blowing through trees all produce similar to white noise. Patients in the intervention group are observed by the investigator on the 0th and 1st postoperative days.Before going to sleep, a bluetooth headset will be used to listen to white noise for 30 minutes and vital signs will be measured before and after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | On the 0th and 1st postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.Patients in the control group will be monitored according to their routine clinical procedures. Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. Patients in the control group will also be followed up at the same times and with the same forms. Receives: Other: White Noise |
| No Intervention Group | No intervention | Patients in the control group will not receive any intervention other than their routine. Data collection forms will be applied to the participants in the control group at the same time as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Sleep Quality Assessed by the Richard Campbell Sleep Scale
The sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale on the 1st and 2nd postoperative days after morning treatment. This scale consists of 6 items and the total score range is 0-100 points. As the scale score increases, the sleep quality of the patients also increases.
Measured: Change from baseline sleep quality at two days after surgery
Change of Comfort Level Assessed by the General Comfort Questionnaire Short Form
The general comfort levels of the patients were evaluated with the General Comfort Questionnaire Short Form after the morning treatment on the 1st and 2nd postoperative days. This scale consists of 28 items and includes three sub-dimensions; comfort, relaxation and relaxation. The scale score is calculated by dividing the total score obtained from the scale by the number of scale items. The scale total score range is between 0-6 points. As the scale score increases, the comfort level of the patients also increases.
Measured: Change from baseline comfort level at two days after surgery
Change of Satisfaction Level Assessed by Visual Analogue Scale
The satisfaction levels of the patients were evaluated with the Visual Analogue Scale on the 1st and 2nd postoperative days, after the morning treatment. This scale consists of 10 cm horizontal lines and is evaluated between 0-10 points. As the scale score increases, the satisfaction level of the patients also increases.
Measured: Change from baseline satisfaction level at two days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start25 May 2022
- Primary completion28 Feb 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-center parallel-group randomized controlled clinical trial. Participants who accepted to participate in the study and met the inclusion criteria will be assigned to the intervention (n=30) or control group (n=30) according to the computer-based randomization table.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci, Saglik Bilimleri Universitesi
- Investigators
- Melike Kızılkaya, RN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687305
- Sponsor's protocol ID
- 27.05.2022-22-36
- Status last verified
- Mar 2024
- First submitted
- 30 Dec 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murase K, Tabara Y, Ito H, Kobayashi M, Takahashi Y, Setoh K, Kawaguchi T, Muro S, Kadotani H, Kosugi S, Sekine A, Yamada R, Nakayama T, Mishima M, Matsuda S, Matsuda F, Chin K. Knee Pain and Low Back Pain Additively Disturb Sleep in the General Population: A Cross-Sectional Analysis of the Nagahama Study. PLoS One. 2015 Oct 7;10(10):e0140058. doi: 10.1371/journal.pone.0140058. eCollection 2015.
PubMed 26444713Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). 2009 May 1;34(10):1094-109. doi: 10.1097/BRS.0b013e3181a105fc.
PubMed 19363455Kavcic N, Grenier S, McGill SM. Quantifying tissue loads and spine stability while performing commonly prescribed low back stabilization exercises. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2319-29. doi: 10.1097/01.brs.0000142222.62203.67.
PubMed 15480148Akiyama A, Tsai JD, W Y Tam E, Kamino D, Hahn C, Go CY, Chau V, Whyte H, Wilson D, McNair C, Papaioannou V, Hugh SC, Papsin BC, Nishijima S, Yamazaki T, Miller SP, Ochi A. The Effect of Music and White Noise on Electroencephalographic (EEG) Functional Connectivity in Neonates in the Neonatal Intensive Care Unit. J Child Neurol. 2021 Jan;36(1):38-47. doi: 10.1177/0883073820947894. Epub 2020 Aug 24.
PubMed 32838628
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Noise on Sleep Quality, Comfort and Satisfaction Level in Patients Undergoing Lumbar Disc Herniation Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05687305
- Acronym / sponsor ID
- 27.05.2022-22-36
- Conditions
- Disc Herniation
- Keywords
- Lumbar Disc Herniation, White Noise, Sleep Quality, Comfort Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 18 Jan 2023 (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 aim of this clinical trial is to determine the effectiveness of listening to white noise on the sleep quality, comfort level, satisfaction level of patients after lumbar disc herniation surgery. The main hypotheses are:
- Is there a difference between the sleep quality of patients who listen to white noise and those who do not?
- Is there a difference between the comfort levels of patients who listen to white noise and those who do not?
- Is there a difference between the satisfaction levels of patients who listen to white noise and those who do not?
The main tasks that the participants will be asked to do will be explained and Their informed consent will be obtained. The two research groups will be compared.
Detailed description
This study will be conducted with a total of 60 patients who underwent surgery for lumbar disc herniation at a hospital in Istanbul. Participants in the study who had lumbar disc herniation surgery will be divided into two groups: intervention (n = 30) and control group (n = 30), according to the randomization method created with computer-based random numbers.
On the 0th and 1st postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.Patients in the control group will be monitored according to their routine clinical procedures. Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. Patients in the control group will also be followed up at the same times and with the same forms. Descriptive Characteristics Form, Informed Consent Form, The Richards-Campbell Sleep Questionnaire, General Comfort Questionnaire,Visual Analog Scale for Satisfaction Level will be used in data collection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-center parallel-group randomized controlled clinical trial. Participants who accepted to participate in the study and met the inclusion criteria will be assigned to the intervention (n=30) or control group (n=30) according to the computer-based randomization table.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: White NoiseOn the 0th and 1st postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.Patients in the control group will be monitored according to their routine clinical procedures. Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. Patients in the control group will also be followed up at the same times and with the same forms. |
| No Intervention Group | No intervention | –Patients in the control group will not receive any intervention other than their routine. Data collection forms will be applied to the participants in the control group at the same time as the intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- underwent lumbar disc herniation surgery
- hospitalized for at least 48 hours
- agreed to participate in research
Key exclusion criteria (2 listed)
- chronic sleep problems and taking medication
- Not filling out the questionnaire
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 |
|---|---|---|
| White NoiseWhite noise is produced by digitally combining sounds of equal frequency in the laboratory. Then, all of the frequencies in this sound are calibrated to generate noise at each frequency. If the contribution of each region to the noise level is the same, the noise is referred to as white noise. Waterfalls, ocean waves, and wind blowing through trees all produce similar to white noise. Patients in the intervention group are observed by the investigator on the 0th and 1st postoperative days.Before going to sleep, a bluetooth headset will be used to listen to white noise for 30 minutes and vital signs will be measured before and after the procedure. | Other | Intervention Group |
Primary outcome
Change of Sleep Quality Assessed by the Richard Campbell Sleep Scale
Time frame: Change from baseline sleep quality at two days after surgery
The sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale on the 1st and 2nd postoperative days after morning treatment. This scale consists of 6 items and the total score range is 0-100 points. As the scale score increases, the sleep quality of the patients also increases.
Change of Comfort Level Assessed by the General Comfort Questionnaire Short Form
Time frame: Change from baseline comfort level at two days after surgery
The general comfort levels of the patients were evaluated with the General Comfort Questionnaire Short Form after the morning treatment on the 1st and 2nd postoperative days. This scale consists of 28 items and includes three sub-dimensions; comfort, relaxation and relaxation. The scale score is calculated by dividing the total score obtained from the scale by the number of scale items. The scale total score range is between 0-6 points. As the scale score increases, the comfort level of the patients also increases.
Change of Satisfaction Level Assessed by Visual Analogue Scale
Time frame: Change from baseline satisfaction level at two days after surgery
The satisfaction levels of the patients were evaluated with the Visual Analogue Scale on the 1st and 2nd postoperative days, after the morning treatment. This scale consists of 10 cm horizontal lines and is evaluated between 0-10 points. As the scale score increases, the satisfaction level of the patients also increases.
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 29 Mar 2024.
- Results publication: PubMed 26444713Murase K, Tabara Y, Ito H, Kobayashi M, Takahashi Y, Setoh K, Kawaguchi T, Muro S, Kadotani H, Kosugi S, Sekine A, Yamada R, Nakayama T, Mishima M, Matsuda S, Matsuda F, Chin K. Knee Pain and Low Back Pain Additively Disturb Sleep in the General Population: A Cross-Sectional Analysis of the Nagahama Study. PLoS One. 2015 Oct 7;10(10):e0140058. doi: 10.1371/journal.pone.0140058. eCollection 2015.
- Results publication: PubMed 19363455Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). 2009 May 1;34(10):1094-109. doi: 10.1097/BRS.0b013e3181a105fc.
- Results publication: PubMed 15480148Kavcic N, Grenier S, McGill SM. Quantifying tissue loads and spine stability while performing commonly prescribed low back stabilization exercises. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2319-29. doi: 10.1097/01.brs.0000142222.62203.67.
- Results publication: PubMed 32838628Akiyama A, Tsai JD, W Y Tam E, Kamino D, Hahn C, Go CY, Chau V, Whyte H, Wilson D, McNair C, Papaioannou V, Hugh SC, Papsin BC, Nishijima S, Yamazaki T, Miller SP, Ochi A. The Effect of Music and White Noise on Electroencephalographic (EEG) Functional Connectivity in Neonates in the Neonatal Intensive Care Unit. J Child Neurol. 2021 Jan;36(1):38-47. doi: 10.1177/0883073820947894. Epub 2020 Aug 24.
- 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.
Melike Kızılkaya, RN principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Noise in people with Disc Herniation, run by Saglik Bilimleri Universitesi 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 3 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 29 Mar 2024. 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?
Change of Sleep Quality Assessed by the Richard Campbell Sleep Scale (time frame: Change from baseline sleep quality at two days after surgery). The study lists 3 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 NCT05687305, which also lists 4 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 29 Mar 2024.