Sleep QualitySEMNCT05988164
"Eye Masks and Post-Surgical Sleep Quality"
A study testing Eye Mask in people with Sleep Quality, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the impact of postoperative eye mask usage on sleep quality in patients who have undergone gynecological surgery. Read more about this study
- Who is it for?
- Ages 25 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Eye Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2023to 30 May 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 25 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who have undergone gynecological surgery Ability to read and speak Turkish participation with the ability to use an eye mask Patients who recovered at least six hours after surgery Patients with no traumatic or pathological head injury history Patients without sleep disorders or mental illnesses
Who cannot join
- Patients with an eye injury Patients who are allergic to eye masks Patients or their families who wish to withdraw from the study Patients with a mental or physical condition that makes participation in the study impossible.
- Patients who cannot speak or read Turkish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Effect of Eye Masks Following Post-Gynecological Surgery on Sleep Quality: A Randomized Study"
The aim of this study is to evaluate the impact of postoperative eye mask usage on sleep quality in patients who have undergone gynecological surgery.
Read the detailed description
Sleep is considered a fundamental need for human health, and it contributes significantly to immune, mental, and physical functions. It has been shown that sleep quality influences individuals' quality of life, and it also promotes the healing process of injured tissues Sleep and rest are essential for optimal performance. In adults, 6-8 hours of sleep per day is required. Along with many unknown aspects of sleep's role in health and diseases, sleep deprivation is directly associated with poor mental and physical functions. In addition to compromising individuals' and public health, sleep deprivation can have severe complications for physical and behavioral functions.
Various factors contribute to sleep disturbances in the hospital environment. Sleep quality can be adversely affected by noise, light, and many other aspects of the surrounding environment. Non-pharmacological and pharmacological treatments can be used to improve sleep quality. Generally, non-invasive and cost-effective intervention methods are being used in hospitals to improve the quality of sleep during hospitalizing patients. Several studies have shown that using non-invasive tools like eye masks positively affects sleep quality. Nevertheless, there is no evidence that this tool is effective in patients undergoing gynecological surgery, and no studies have been founded locally to address this issue. Therefore, this study aims to examine sleep quality in women following gynecological surgery with eye masks.
Method:
A quasi-experimental design with a pre-test and post-test control group approach was used in this study. The quasi-experiment method uses a control group for experimental research. Two groups were randomly selected. There is an intervention group and a control group. Twenty-five participants participated in the intervention and 25 in the control group.
Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at night. The Richard-Campbell Sleep Scale will be used to measure patients' perceptions of sleep quality. The control group will undergo no intervention, and their sleep quality will be measured in the hospital setting using the Richard-Campbell Sleep Scale. Richards developed the Richard-Campbell Sleep Scale (RCSS) in 1987, and Karaman Zlü and Zer conducted its Turkish validity and reliability study in 2015. The scale consists of six items that evaluate the depth of nocturnal sleep, sleep onset latency, frequency of awakenings, duration of wakefulness after sleep onset, sleep quality, and noise level in the environment. Scale items are evaluated from 0 to 100 on a visual analog scale. Scores between "0-25" indicate very poor sleep, while scores between "76-100" indicate very good sleep. Participants' demographic characteristics, such as age, gender, narcotic drug consumption, average sleep duration before hospitalization, and sleep-facilitating tools, will be recorded on a participant information form developed in accordance with the literature. The post-test Richard-Campbell Sleep Scale will be used in the morning to assess sleep quality.
- Conditions
- Sleep Quality
- Being tested
- Eye Mask
- Keywords
- Eye Mask, Sleep Quality, Gynecological Surgeries, Hospitalization, Health Care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye MaskOther
Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier.
| Study group | Role | What they receive |
|---|---|---|
| Eye mask Group | Experimental | Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at night. To measure patients' perception of sleep quality, we will use the Richard-Campbell Sleep Scale. The following morning, we will complete the post-test Richard-Campbell Sleep Scale to assess sleep quality. Receives: Other: Eye Mask |
| control Group | No intervention | The control group will undergo no intervention, and their sleep quality will be measured in the hospital setting using the Richard-Campbell Sleep Scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improving sleep quality with eye mask following gynecological surgery
Sleep quality and duration are increased in patients undergoing gynecological surgery with the use of postoperative eye masks. This results in reduced sleep interruptions and improved overall healthcare satisfaction and well-being of patients.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start5 Oct 2023
- Primary completion29 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is an intervention group and a control group. Twenty-five participants participated in the intervention and 25 in the control group. Patients in the intervention group will be given eye masks and asked to sleep with them
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kevser Ozdemir, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988164
- Sponsor's protocol ID
- SAU-FHS-KI-02
- Acronym
- SEM
- Status last verified
- May 2024
- First submitted
- 4 Aug 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to our ethics committee rules, there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Eye Masks Following Post-Gynecological Surgery on Sleep Quality: A Randomized Study"
- ClinicalTrials.gov ID
- NCT05988164
- Acronym / sponsor ID
- SEM / SAU-FHS-KI-02
- Conditions
- Sleep Quality
- Keywords
- Eye Mask, Sleep Quality, Gynecological Surgeries, Hospitalization, Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 29 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 14 Aug 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 study is to evaluate the impact of postoperative eye mask usage on sleep quality in patients who have undergone gynecological surgery.
Detailed description
Sleep is considered a fundamental need for human health, and it contributes significantly to immune, mental, and physical functions. It has been shown that sleep quality influences individuals' quality of life, and it also promotes the healing process of injured tissues Sleep and rest are essential for optimal performance. In adults, 6-8 hours of sleep per day is required. Along with many unknown aspects of sleep's role in health and diseases, sleep deprivation is directly associated with poor mental and physical functions. In addition to compromising individuals' and public health, sleep deprivation can have severe complications for physical and behavioral functions.
Various factors contribute to sleep disturbances in the hospital environment. Sleep quality can be adversely affected by noise, light, and many other aspects of the surrounding environment. Non-pharmacological and pharmacological treatments can be used to improve sleep quality. Generally, non-invasive and cost-effective intervention methods are being used in hospitals to improve the quality of sleep during hospitalizing patients. Several studies have shown that using non-invasive tools like eye masks positively affects sleep quality. Nevertheless, there is no evidence that this tool is effective in patients undergoing gynecological surgery, and no studies have been founded locally to address this issue. Therefore, this study aims to examine sleep quality in women following gynecological surgery with eye masks.
Method:
A quasi-experimental design with a pre-test and post-test control group approach was used in this study. The quasi-experiment method uses a control group for experimental research. Two groups were randomly selected. There is an intervention group and a control group. Twenty-five participants participated in the intervention and 25 in the control group.
Patients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at night. The Richard-Campbell Sleep Scale will be used to measure patients' perceptions of sleep quality. The control group will undergo no intervention, and their sleep quality will be measured in the hospital setting using the Richard-Campbell Sleep Scale. Richards developed the Richard-Campbell Sleep Scale (RCSS) in 1987, and Karaman Zlü and Zer conducted its Turkish validity and reliability study in 2015. The scale consists of six items that evaluate the depth of nocturnal sleep, sleep onset latency, frequency of awakenings, duration of wakefulness after sleep onset, sleep quality, and noise level in the environment. Scale items are evaluated from 0 to 100 on a visual analog scale. Scores between "0-25" indicate very poor sleep, while scores between "76-100" indicate very good sleep. Participants' demographic characteristics, such as age, gender, narcotic drug consumption, average sleep duration before hospitalization, and sleep-facilitating tools, will be recorded on a participant information form developed in accordance with the literature. The post-test Richard-Campbell Sleep Scale will be used in the morning to assess sleep quality.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There is an intervention group and a control group. Twenty-five participants participated in the intervention and 25 in the control group. Patients in the intervention group will be given eye masks and asked to sleep with them
| Arm | Type | Receives |
|---|---|---|
| Eye mask Group | Experimental | Other: Eye MaskPatients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. Researchers or nurses will assist patients who cannot wear an eye mask at night. To measure patients' perception of sleep quality, we will use the Richard-Campbell Sleep Scale. The following morning, we will complete the post-test Richard-Campbell Sleep Scale to assess sleep quality. |
| control Group | No intervention | –The control group will undergo no intervention, and their sleep quality will be measured in the hospital setting using the Richard-Campbell Sleep Scale. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women who have undergone gynecological surgery Ability to read and speak Turkish participation with the ability to use an eye mask Patients who recovered at least six hours after surgery Patients with no traumatic or pathological head injury history Patients without sleep disorders or mental illnesses
Key exclusion criteria (2 listed)
- Patients with an eye injury Patients who are allergic to eye masks Patients or their families who wish to withdraw from the study Patients with a mental or physical condition that makes participation in the study impossible.
- Patients who cannot speak or read Turkish
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 |
|---|---|---|
| Eye MaskPatients in the intervention group will be given eye masks and asked to sleep with them at 22:00 or earlier. | Other | Eye mask Group |
Primary outcome
Improving sleep quality with eye mask following gynecological surgery
Time frame: 9 months
Sleep quality and duration are increased in patients undergoing gynecological surgery with the use of postoperative eye masks. This results in reduced sleep interruptions and improved overall healthcare satisfaction and well-being of patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No. According to our ethics committee rules, there is no plan to make individual participant data (IPD) available to other researchers.
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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 Eye Mask in people with Sleep Quality, run by Sakarya 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 1 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: status not confirmed, as of the sponsor's last update on 29 May 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?
Results are not available in the source record.
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?
Improving sleep quality with eye mask following gynecological surgery (time frame: 9 months). 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 29 May 2024.