Hemodialysis ComplicationNCT05980845
The Effect Nature Sounds and Music on Hemodialysis Patients
A study testing Nature sounds in people with Hemodialysis Complication and Anxiety, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted as a randomized controlled experimental research to examine the effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Complication, Anxiety
- What is being tested?
- Nature sounds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2019to 8 Jul 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 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- Age range between 18 and 79,
- Receiving HD treatment for at least six months,
- Receiving three sessions of HD treatment per week on a regular outpatient basis at the same institution.
Who cannot join
- Any problem that prevents cognitive, affective and verbal communication,
- Having any psychiatric condition,
- Use of anxiolytic medication,
- Out of the criteria for inclusion in the study,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, 15000
About this study
Official title: The Effect of Nature Sounds and Music on Vital Signs and Anxiety Levels of Hemodialysis Patients
The study was conducted as a randomized controlled experimental research to examine the effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients.
The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who received treatment in the hemodialysis units of three hospitals, one university, one education research and one state hospital in Antalya province, met the inclusion criteria and consented to participate in the study. Patients were homogenously divided into intervention (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age, gender and hemodialysis duration. Patients in the intervention group were subjected to nature sounds/music during the hemodialysis procedure, while patients in the control group were not subjected to any intervention during the procedure. The data were collected by face-to-face interview technique using the "Descriptive Characteristics Form", "Vital Signs Monitoring Form", "State Anxiety Inventory" and "Trait Anxiety Inventory". Ethics committee approval, institutional permissions and written consent of the patients were obtained for the implementation of the study. Number, percentage, mean, standard deviation, minimum and maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests, the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.
- Conditions
- Hemodialysis Complication, Anxiety
- Being tested
- Nature sounds
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature soundsBehavioural
Also called music
Nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Active comparator | It was explained to the patients in the nature sounds group that nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over. The patients listened to nature sounds for 30 minutes in three HD sessions for one week under the supervision of the researcher. Receives: Behavioral: Nature sounds |
| Control Group | No intervention | Patients in the control group were not intervened by the researcher during the HD sessions. Before the first HD session started, the "Descriptive Characteristics Form" and "Trait Anxiety Scale" were performed by the researcher while the patients were in the waiting room. Then, in every three HD sessions for one week, when the patients went to their beds, their vital signs were measured and recorded on the "Vital Signs Monitoring Form" and the "State Anxiety Scale" was administered just before the HD treatment session was started. Then, the vital signs of the patients were measured and recorded on the "Vital Signs Monitoring Form" at the 30th minute, 1st, 2nd, 3rd hour of the HD session and immediately after the end of the HD session. At the same time, the "State Anxiety Scale" was performed again immediately after the end of the HD session. The patient was then transferred out of the unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale (SAS)
State Anxiety Scale (SAS) is used to determine how an individual feels at a certain moment and under certain conditions. According to the degree of severity of the emotions, thoughts or behaviors expressed by the items, "not at all" (1), "a little" (2), "a lot" (3), "completely" (4) in the scale. Some of the items in the scale are direct statements and some of them are reversed statements.
Measured: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
The Trait Anxiety Scale (TAS)
The Trait Anxiety Scale (TAS) is used to determine how the individual usually perceives themselves. The items are scored as "almost never" (1), "sometimes" (2), "very often" (3) and "almost always" (4) according to the frequency of the feelings, thoughts or behaviors expressed by the items. The items in the scale are in the form of direct and inverted statements.
Measured: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start6 Sep 2019
- Primary completion21 Mar 2020
- Study completion8 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IMarasli, Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980845
- Sponsor's protocol ID
- 12.09.2018-4
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All authors contributed to the interpretation, writing, and approval of the final manuscript.
Publications
Hagemann PMS, Martin LC, Neme CMB. The effect of music therapy on hemodialysis patients' quality of life and depression symptoms. J Bras Nefrol. 2019 Jan-Mar;41(1):74-82. doi: 10.1590/2175-8239-jbn-2018-0023. Epub 2018 Sep 13.
PubMed 30222176Kim Y, Evangelista LS, Park YG. Anxiolytic Effects of Music Interventions in Patients Receiving Incenter Hemodialysis: A Systematic Review and Meta-Analysis. Nephrol Nurs J. 2015 Jul-Aug;42(4):339-47; quiz 348.
PubMed 26462307
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nature Sounds and Music on Vital Signs and Anxiety Levels of Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05980845
- Acronym / sponsor ID
- 12.09.2018-4
- Conditions
- Hemodialysis Complication, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 21 Mar 2020 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 8 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 study was conducted as a randomized controlled experimental research to examine the effect of nature sounds and music on vital signs and anxiety levels of hemodialysis patients.
The study was conducted between September 6, 2019 and March 21, 2020 with 75 patients who received treatment in the hemodialysis units of three hospitals, one university, one education research and one state hospital in Antalya province, met the inclusion criteria and consented to participate in the study. Patients were homogenously divided into intervention (nature sound group n=25 and music group n=25) and control (n=25) groups on the basis of age, gender and hemodialysis duration. Patients in the intervention group were subjected to nature sounds/music during the hemodialysis procedure, while patients in the control group were not subjected to any intervention during the procedure. The data were collected by face-to-face interview technique using the "Descriptive Characteristics Form", "Vital Signs Monitoring Form", "State Anxiety Inventory" and "Trait Anxiety Inventory". Ethics committee approval, institutional permissions and written consent of the patients were obtained for the implementation of the study. Number, percentage, mean, standard deviation, minimum and maximum, the the Shapiro Wilk normality test, One-Way Analysis of Variance, Chi-Square tests, the Kruskal Wallis test, Dunn-Bonferroni test, Tukey HSD, Three-Way Analysis of Variance and Bonferroni Corrected Two Ratio Z test were employed in the evaluation of the data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Active comparator | Behavioral: Nature soundsIt was explained to the patients in the nature sounds group that nature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over. The patients listened to nature sounds for 30 minutes in three HD sessions for one week under the supervision of the researcher. |
| Control Group | No intervention | –Patients in the control group were not intervened by the researcher during the HD sessions. Before the first HD session started, the "Descriptive Characteristics Form" and "Trait Anxiety Scale" were performed by the researcher while the patients were in the waiting room. Then, in every three HD sessions for one week, when the patients went to their beds, their vital signs were measured and recorded on the "Vital Signs Monitoring Form" and the "State Anxiety Scale" was administered just before the HD treatment session was started. Then, the vital signs of the patients were measured and recorded on the "Vital Signs Monitoring Form" at the 30th minute, 1st, 2nd, 3rd hour of the HD session and immediately after the end of the HD session. At the same time, the "State Anxiety Scale" was performed again immediately after the end of the HD session. The patient was then transferred out of the unit. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study
- Age range between 18 and 79,
- Receiving HD treatment for at least six months,
- Receiving three sessions of HD treatment per week on a regular outpatient basis at the same institution.
Key exclusion criteria (4 listed)
- Any problem that prevents cognitive, affective and verbal communication,
- Having any psychiatric condition,
- Use of anxiolytic medication,
- Out of the criteria for inclusion in the study,
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 |
|---|---|---|
| Nature soundsAlso: musicNature sounds would be played for 30 minutes in three HD sessions for one week, starting from the beginning of the session. Afterwards, the patients were informed about the usage of the Mp3 player and in-ear headphones, they were demonstrated that they could adjust the volume to the level they desired, and it was stated that they should not detach the headphones until the 30-minute recording was over. | Behavioural | Assigned Interventions |
Primary outcome
State Anxiety Scale (SAS)
Time frame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
State Anxiety Scale (SAS) is used to determine how an individual feels at a certain moment and under certain conditions. According to the degree of severity of the emotions, thoughts or behaviors expressed by the items, "not at all" (1), "a little" (2), "a lot" (3), "completely" (4) in the scale. Some of the items in the scale are direct statements and some of them are reversed statements.
The Trait Anxiety Scale (TAS)
Time frame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes
The Trait Anxiety Scale (TAS) is used to determine how the individual usually perceives themselves. The items are scored as "almost never" (1), "sometimes" (2), "very often" (3) and "almost always" (4) according to the frequency of the feelings, thoughts or behaviors expressed by the items. The items in the scale are in the form of direct and inverted statements.
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 8 Aug 2023.
- Results publication: PubMed 30222176Hagemann PMS, Martin LC, Neme CMB. The effect of music therapy on hemodialysis patients' quality of life and depression symptoms. J Bras Nefrol. 2019 Jan-Mar;41(1):74-82. doi: 10.1590/2175-8239-jbn-2018-0023. Epub 2018 Sep 13.
- Results publication: PubMed 26462307Kim Y, Evangelista LS, Park YG. Anxiolytic Effects of Music Interventions in Patients Receiving Incenter Hemodialysis: A Systematic Review and Meta-Analysis. Nephrol Nurs J. 2015 Jul-Aug;42(4):339-47; quiz 348.
- Individual participant dataSharing planned: No. All authors contributed to the interpretation, writing, and approval of the final manuscript.
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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 Nature sounds in people with Hemodialysis Complication and Anxiety, run by Mehmet Akif Ersoy 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 4 inclusion and 4 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 8 Aug 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 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?
State Anxiety Scale (SAS) (time frame: Change in anxiety score during Nature Sounds and Music, an average of 10 minutes). 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 NCT05980845, which also lists 2 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 8 Aug 2023.