Patient EngagementNCT07404813
The Effect of Family Member Voices on Dopamine, Serotonin Levels, and Pain in Patients in Intensive Care Units
A study testing Experimental Group in people with Patient Engagement and Intensive Care (ICU), run by Zeliha CENGİZ at 2 sites in Turkey (Türkiye).
Trial summary
In intensive care units, the frequent use of analgesics leads to polypharmacy and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patient Engagement, Intensive Care (ICU), Family Members' Voices
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be between 18 and 65 years old.
- Must be admitted to an intensive care unit (ICU).
- Must not have been fed in the last hour.
- Glasgow Coma Scale (GCS) score between 3 and 8.
- To agitation in deep coma, the Richmond Agitation-Sedation Scale (RASS) score must be between -3 and +2.
Who cannot join
- Having a known hearing-related illness or having undergone a surgical procedure involving the ear.
- Having taken any of the hormones cortisol, serotonin, or dopamine within the last 48 hours.
- Having taken any analgesic within the last 4 hours.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Malatya Turgut Ozal Medical Center
Malatya, Malatya, 44000
Şırnak Üniversitesi
Şırnak, Merkez, 73000
About this study
In intensive care units, the frequent use of analgesics leads to polypharmacy and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their quality of life. Listening to the voices of family members is expected to have positive effects on patients due to its ease of implementation, low cost, and non-invasive nature.
Read the detailed description
In intensive care units, the frequent use of analgesics leads to excessive medication use and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their quality of life. Listening to the voices of family members is expected to have positive effects on patients due to its ease of implementation, low cost, and non-invasive nature. This study was planned to be conducted between 01.03.2025 and 01.03.2026 at İnönü University Turgut Özal Medical Center General Surgery Intensive Care, Neurology Intensive Care, and Neurosurgery Intensive Care units. The aim was to determine the effects of family members' voices on dopamine and serotonin levels and pain in ICU patients, as well as family members' satisfaction levels. The study was designed as a randomized controlled trial. The sample for the study would consist of 78 ICU patients (experimental group = 39, control group = 39) treated in these clinics, determined by power analysis for the data collection dates. In the experimental group, recordings of emotionally charged voices from family members were played to patients using headphones for a total of 40 minutes, structured as 2 sets of 20 minutes each with a 10-minute rest between applications. In both groups, behavioral pain assessment was planned at 0, 20, and 50 minutes, and dopamine and serotonin levels would be measured from venous blood samples. To collect study data, a Personal Information Form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and a family member satisfaction questionnaire (FS-ICU-24) were used. Power analysis conducted with the G*Power program considered an effect size of 0.20, a significance level of 0.05, a 95% confidence interval, and 0.95 power.
- Being tested
- Experimental Group
- Keywords
- Relatives' Voices, Pain,, serotonin, Dopamine, Satisfaction
- Medical subject headings
- Patient Participation, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
The patients' relatives were given a detailed explanation of the procedures and were asked to fill out a patient/family satisfaction questionnaire. The topics to be discussed by the patient's family members were defined within a framework, and audio recordings were obtained. At 0 minutes, 5 mL of venous blood was drawn to assess dopamine and serotonin levels, and behavioral pain scores were recorded. Between 0 and 20 minutes, for 20 minutes, the audio recordings were played to the patient via headphones, 5 mL of venous blood was drawn again to assess dopamine and serotonin levels, and behavioral pain scores were recorded. At 10 minutes, the headphones were removed and the patient was exposed to normal ICU sounds. Between 30 and 50 minutes, again for 20 minutes, the audio recordings were played to the patient via headphones, 5 mL of venous blood was drawn again to assess dopamine and serotonin levels, and behavioral pain scores were recorded.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In the experimental group, patients were exposed to a protocol consisting of emotional-content audio recordings obtained from close relatives, each 20 minutes long, with a 10-minute rest between applications, arranged as two sets, and delivered via headphones for a total of 40 minutes. In the experimental group, behavioral pain assessments were conducted at 0, 20, and 50 minutes, and dopamine and serotonin levels were measured from venous blood samples. To collect study data, a personal information form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and the FS-ICU-24 patient/family satisfaction questionnaire were used. Receives: Other: Experimental Group |
| control group | No intervention | In this group, no intervention is performed, and the patients are exposed to ICU sounds. For the control group, at 0 minutes 5 mL (5 cc) of venous blood was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded. From 0 to 20 minutes, no intervention was performed; however, the patients were exposed to intensive-care unit (ICU) sounds for 20 minutes. A 5 mL venous blood sample was drawn again to check dopamine and serotonin levels, and behavioral pain scores were recorded. The patients were then exposed to normal ICU sounds for 10 additional minutes. From 30 to 50 minutes, again without any intervention, patients were exposed to ICU sounds for 20 minutes; a 5 mL venous blood sample was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared with Baseline, at 20 And 50 Minutes after The Patient-Family Voice Recordings Were Played, Dopamine and Serotonin Levels İncreased and Pain Decreased According to The Behavioral Pain Scale.
An increase in dopamine and serotonin levels in the venous blood of patients compared with the control group, and a low score on the measured Behavioral Pain Scale relative to baseline (with 10 being the highest and 1 the lowest), would indicate that the audio recordings are a positive intervention.
Measured: Changes in dopamine, serotonin, and pain at 0, 20, and 50 minutes after the patient's family voices were played.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start20 Feb 2025
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
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 Patient EngagementStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the experimental group, patients were exposed to a protocol consisting of emotional-content audio recordings obtained from close relatives, each 20 minutes long, with a 10-minute rest between applications, arranged as two sets, and delivered via headphones for a total of 40 minutes. In both groups, behavioral pain assessments were conducted at 0, 20, and 50 minutes, and dopamine and serotonin levels were measured from venous blood samples. To collect study data, a personal information form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and a family/patient relative satisfaction questionnaire (FS-ICU-24) were used. For the control group, at 0 minutes 5 mL (5 cc) of venous blood was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded. From 0 to 20 minutes, no intervention was performed; however, the patients were exposed to intensive-care unit (ICU) sounds for 20 minutes. A 5 mL venous blood sample was drawn again to
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeliha CENGİZ
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404813
- Sponsor's protocol ID
- 2024/59
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu WC, Chiang MC, Lin KC, Chang CC, Lin KH, Chen CW. Effects of maternal voice on pain and mother-Infant bonding in premature infants in Taiwan: A randomized controlled trial. J Pediatr Nurs. 2022 Mar-Apr;63:e136-e142. doi: 10.1016/j.pedn.2021.09.022. Epub 2021 Sep 30.
PubMed 34602338Tıbık, R., & Şener, D. K. (2024). Preterm Yenidoğanlara Orogastrik Tüp Takma İşlemi Sırasında Dinletilen Anne Sesi ve Beyaz Gürültünün Ağrı Düzeyi ve Fizyolojik Parametrelere Etkisi: Randomize Kontrollü Çalışma. Bandırma Onyedi Eylül Üniversitesi Sağlık Bilimleri ve Araştırmaları Dergisi, 6(1), 109-119.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family Member Voices on Dopamine, Serotonin Levels, and Pain in Patients in Intensive Care Units
- ClinicalTrials.gov ID
- NCT07404813
- Acronym / sponsor ID
- 2024/59
- Keywords
- Relatives' Voices, Pain,, serotonin, Dopamine, Satisfaction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Zeliha CENGİZUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 11 Feb 2026 (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.
In intensive care units, the frequent use of analgesics leads to polypharmacy and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their quality of life. Listening to the voices of family members is expected to have positive effects on patients due to its ease of implementation, low cost, and non-invasive nature.
Detailed description
In intensive care units, the frequent use of analgesics leads to excessive medication use and increased costs for patients. By embracing a patient-centered care principle, nursing believes that patients may be happier and experience reduced pain when they hear the voices of their familiar ones, thereby directly improving their quality of life. Listening to the voices of family members is expected to have positive effects on patients due to its ease of implementation, low cost, and non-invasive nature. This study was planned to be conducted between 01.03.2025 and 01.03.2026 at İnönü University Turgut Özal Medical Center General Surgery Intensive Care, Neurology Intensive Care, and Neurosurgery Intensive Care units. The aim was to determine the effects of family members' voices on dopamine and serotonin levels and pain in ICU patients, as well as family members' satisfaction levels. The study was designed as a randomized controlled trial. The sample for the study would consist of 78 ICU patients (experimental group = 39, control group = 39) treated in these clinics, determined by power analysis for the data collection dates. In the experimental group, recordings of emotionally charged voices from family members were played to patients using headphones for a total of 40 minutes, structured as 2 sets of 20 minutes each with a 10-minute rest between applications. In both groups, behavioral pain assessment was planned at 0, 20, and 50 minutes, and dopamine and serotonin levels would be measured from venous blood samples. To collect study data, a Personal Information Form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and a family member satisfaction questionnaire (FS-ICU-24) were used. Power analysis conducted with the G*Power program considered an effect size of 0.20, a significance level of 0.05, a 95% confidence interval, and 0.95 power.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the experimental group, patients were exposed to a protocol consisting of emotional-content audio recordings obtained from close relatives, each 20 minutes long, with a 10-minute rest between applications, arranged as two sets, and delivered via headphones for a total of 40 minutes. In both groups, behavioral pain assessments were conducted at 0, 20, and 50 minutes, and dopamine and serotonin levels were measured from venous blood samples. To collect study data, a personal information form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and a family/patient relative satisfaction questionnaire (FS-ICU-24) were used. For the control group, at 0 minutes 5 mL (5 cc) of venous blood was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded. From 0 to 20 minutes, no intervention was performed; however, the patients were exposed to intensive-care unit (ICU) sounds for 20 minutes. A 5 mL venous blood sample was drawn again to
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Experimental GroupIn the experimental group, patients were exposed to a protocol consisting of emotional-content audio recordings obtained from close relatives, each 20 minutes long, with a 10-minute rest between applications, arranged as two sets, and delivered via headphones for a total of 40 minutes. In the experimental group, behavioral pain assessments were conducted at 0, 20, and 50 minutes, and dopamine and serotonin levels were measured from venous blood samples. To collect study data, a personal information form, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Behavioral Pain Scale, and the FS-ICU-24 patient/family satisfaction questionnaire were used. |
| control group | No intervention | –In this group, no intervention is performed, and the patients are exposed to ICU sounds. For the control group, at 0 minutes 5 mL (5 cc) of venous blood was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded. From 0 to 20 minutes, no intervention was performed; however, the patients were exposed to intensive-care unit (ICU) sounds for 20 minutes. A 5 mL venous blood sample was drawn again to check dopamine and serotonin levels, and behavioral pain scores were recorded. The patients were then exposed to normal ICU sounds for 10 additional minutes. From 30 to 50 minutes, again without any intervention, patients were exposed to ICU sounds for 20 minutes; a 5 mL venous blood sample was drawn to measure dopamine and serotonin levels, and behavioral pain scores were recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be between 18 and 65 years old.
- Must be admitted to an intensive care unit (ICU).
- Must not have been fed in the last hour.
- Glasgow Coma Scale (GCS) score between 3 and 8.
- To agitation in deep coma, the Richmond Agitation-Sedation Scale (RASS) score must be between -3 and +2.
Key exclusion criteria (3 listed)
- Having a known hearing-related illness or having undergone a surgical procedure involving the ear.
- Having taken any of the hormones cortisol, serotonin, or dopamine within the last 48 hours.
- Having taken any analgesic within the last 4 hours.
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 |
|---|---|---|
| Experimental GroupThe patients' relatives were given a detailed explanation of the procedures and were asked to fill out a patient/family satisfaction questionnaire. The topics to be discussed by the patient's family members were defined within a framework, and audio recordings were obtained. At 0 minutes, 5 mL of venous blood was drawn to assess dopamine and serotonin levels, and behavioral pain scores were recorded. Between 0 and 20 minutes, for 20 minutes, the audio recordings were played to the patient via headphones, 5 mL of venous blood was drawn again to assess dopamine and serotonin levels, and behavioral pain scores were recorded. At 10 minutes, the headphones were removed and the patient was exposed to normal ICU sounds. Between 30 and 50 minutes, again for 20 minutes, the audio recordings were played to the patient via headphones, 5 mL of venous blood was drawn again to assess dopamine and serotonin levels, and behavioral pain scores were recorded. | Other | experimental group |
Primary outcome
Compared with Baseline, at 20 And 50 Minutes after The Patient-Family Voice Recordings Were Played, Dopamine and Serotonin Levels İncreased and Pain Decreased According to The Behavioral Pain Scale.
Time frame: Changes in dopamine, serotonin, and pain at 0, 20, and 50 minutes after the patient's family voices were played.
An increase in dopamine and serotonin levels in the venous blood of patients compared with the control group, and a low score on the measured Behavioral Pain Scale relative to baseline (with 10 being the highest and 1 the lowest), would indicate that the audio recordings are a positive intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Results publication: PubMed 34602338Yu WC, Chiang MC, Lin KC, Chang CC, Lin KH, Chen CW. Effects of maternal voice on pain and mother-Infant bonding in premature infants in Taiwan: A randomized controlled trial. J Pediatr Nurs. 2022 Mar-Apr;63:e136-e142. doi: 10.1016/j.pedn.2021.09.022. Epub 2021 Sep 30.
- Results publicationTıbık, R., & Şener, D. K. (2024). Preterm Yenidoğanlara Orogastrik Tüp Takma İşlemi Sırasında Dinletilen Anne Sesi ve Beyaz Gürültünün Ağrı Düzeyi ve Fizyolojik Parametrelere Etkisi: Randomize Kontrollü Çalışma. Bandırma Onyedi Eylül Üniversitesi Sağlık Bilimleri ve Araştırmaları Dergisi, 6(1), 109-119.
- Tıbık, R. ve Şener, DK (2024). Preterm Yenidoğanlara Orogastrik Tüp Takma İşlemi Sırasında Dinletilen Anne Sesi ve Beyaz yağının Ağrı Düzeyi ve Fizyolojik Parametrelere Etkisi: Rastgele Kontrollü Çalışma.Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group in people with Patient Engagement and Intensive Care (ICU), run by Zeliha CENGİZ at 2 sites 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: enrolling by invitation, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Compared with Baseline, at 20 And 50 Minutes after The Patient-Family Voice Recordings Were Played, Dopamine and Serotonin Levels İncreased and Pain Decreased According to The Behavioral Pain Scale. (time frame: Changes in dopamine, serotonin, and pain at 0, 20, and 50 minutes after the patient's family voices were played.). 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 NCT07404813, 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 11 Feb 2026.