PainQRCMNCT06713044
Effect of Quranic Recitation and Classical Music on Pain Intensity and Interleukin-6 Levels After Lower Limb Orthopedic Surgery With Intrathecal Anesthesia
A study testing Murottal Therapy Intervention Name: Murottal (Islamic verse recitation) and Classical Music Therapy Intervention Name: Classical Music Listening in people with Pain and Pain, Postoperative, run by Universitas Jenderal Soedirman at 1 site in Indonesia.
Trial summary
The goal of this study is to determine the effect of murottal and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Pain, Postoperative, Inflammation
- What is being tested?
- Murottal Therapy Intervention Name: Murottal (Islamic verse recitation) and Classical Music Therapy Intervention Name: Classical Music Listening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2024to 30 Mar 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All Muslim patients who are scheduled for elective lower extremity orthopedic surgery during the study period.
- Patients aged 18 to 60 years.
- Patients who agree to participate in the study.
- Lower extremity orthopedic surgery (ORIF, OREF, and bone replacement) with a minimum surgery duration of 60 minutes.
Who cannot join
- Patients with consciousness disorders
- Patients with neurological disorders
- Patients with cognitive disorders
- Patients with more than 3 spinal attempts
- Patients with hearing impairments
- BMI < 18 and > 39 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Prof. Dr. Margono Soekarjo Hospital
Purwokerto, Central Java, 53146
Prof. Dr. Margono Soekarjo Hospital Prof. Dr. Margono Soekarjo Hospital, +62281-632708, rsmargono@jatengprov.go.id
About this study
Official title: The Effect of Quranic Recitation and Classical Music on Postoperative Pain Intensity and Interleukin-6 Levels in Lower Limb Orthopedic Surgery With Intrathecal Anesthesia
The goal of this study is to determine the effect of murottal and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia. This study also aims to evaluate whether these therapies can help reduce pain and influence the body's inflammatory response.
Main questions to be answered:
Read more
Can murottal or classical music reduce postoperative pain intensity in patients? Can the use of murottal or classical music lower the levels of interleukin 6, an inflammatory marker, in patients after lower extremity orthopedic surgery?
Participants will:
Listen to murottal or classical music during their lower extremity orthopedic surgery with spinal anesthesia.
Measure pain intensity and interleukin 6 levels before and after the intervention to assess the effect of the therapy.
Undergo routine checkups to ensure the safety and success of the therapy. This study aims to provide a deeper understanding of the use of non-pharmacological therapies such as murottal and classical music in managing pain and the inflammatory response in patients after orthopedic surgery.
Read the detailed description
This study aims to explore the impact of murottal (recitations of Islamic verses) and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia. Murottal and classical music are considered non-pharmacological interventions and have been suggested to have a calming effect that may help reduce pain and manage inflammation.
During the study, participants will be randomly assigned to receive either murottal, classical music, or standard postoperative care. Participants in the murottal group will listen to selected recitations durante operation, while participants in the classical music group will listen to classical music compositions.
Pain intensity will be assessed using a numeric rating scale (NRS) both before and after the intervention. Interleukin 6 levels, an inflammatory marker, will be measured using blood samples taken at the same intervals.
The goal is to determine whether these therapeutic interventions can help reduce pain and inflammation, as indicated by interleukin 6 levels, compared to standard care alone. Regular check-ups will be conducted to monitor safety and ensure the success of the therapy.
The findings of this study will help provide insights into the potential use of non-pharmacological interventions, such as murottal and classical music, in managing pain and inflammation in postoperative patients, with the potential to improve recovery outcomes
- Being tested
- Murottal Therapy Intervention Name: Murottal (Islamic verse recitation), Classical Music Therapy Intervention Name: Classical Music Listening, Standard Care (in control arm)
- Keywords
- Quranic Recitation, Classical Music Therapy, Pain Management, Inflammation IL 6, Non-Pharmacological Intervention
- Medical subject headings
- Pain, Pain, Postoperative, Inflammation, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Murottal Therapy Intervention Name: Murottal (Islamic verse recitation)Device
To evaluate whether murottal recitations can reduce postoperative pain intensity and lower interleukin 6 levels, which are indicative of inflammation.
Classical Music Therapy Intervention Name: Classical Music ListeningDevice
To evaluate the impact of classical music on reducing postoperative pain intensity and interleukin 6 levels in the body, thereby managing inflammation.
Standard Care (in control arm)Other
To serve as a control group no intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Murottal Therapy | Experimental | Arm 1: Murottal Therapy
Intervention: Participants in this group will listen to selected recitations of Islamic verses (murottal) as a non-pharmacological intervention during their postoperative recovery. Receives: Device: Murottal Therapy Intervention Name: Murottal (Islamic verse recitation) |
| Arm 2: Classical Music Therapy | Experimental | Intervention: Participants in this group will listen to selected classical music compositions during their recovery from lower extremity orthopedic surgery with spinal anesthesia. Receives: Device: Classical Music Therapy Intervention Name: Classical Music Listening |
| Arm 3: Standard Care | Experimental | Participants in this group will receive standard postoperative care following their surgery, without any additional interventions. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Postoperatively
Primary Outcome Measure 1: Pain Intensity Postoperatively Description: This measure will assess the intensity of pain experienced by participants after surgery.
Method of Measurement: Numeric Rating Scale (NRS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Measured: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
Interleukin-6 (IL-6) Levels Postoperatively
Primary Outcome Measure 2: Interleukin-6 Levels Postoperatively Description: This measure will evaluate the levels of IL-6, a marker for inflammation, following surgery.
Method of Measurement: Blood sample analysis, expressed in picograms per milliliter (pg/mL)
Measured: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Sep 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled trial with a parallel assignment study design. Participants will be randomly allocated to one of three groups: Murottal Group: Participants will listen to selected Islamic recitations (murottal) as a therapeutic intervention during their postoperative recovery. Classical Music Group: Participants will listen to selected classical music pieces to evaluate its impact on postoperative pain and inflammation. Standard Care Group: Participants will receive standard postoperative care without any additional therapeutic interventions. The goal is to assess and compare the effectiveness of murottal and classical music in reducing postoperative pain intensity and inflammation (measured by interleukin 6 levels), compared to the standard care. Randomization ensures unbiased distribution among the groups, and the parallel design enables simultaneous assessment of the interventions' effects in different groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Jenderal Soedirman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guruh Perkasa, Universitas Jenderal Soedirman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713044
- Sponsor's protocol ID
- 420/08774
- Acronym
- QRCM
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
The Effect of Music Therapy on Pain, Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: A Randomized Controlled Trial Ibrahim Karagoz. et al.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Quranic Recitation and Classical Music on Postoperative Pain Intensity and Interleukin-6 Levels in Lower Limb Orthopedic Surgery With Intrathecal Anesthesia
- ClinicalTrials.gov ID
- NCT06713044
- Acronym / sponsor ID
- QRCM / 420/08774
- Keywords
- Quranic Recitation, Classical Music Therapy, Pain Management, Inflammation IL 6, Non-Pharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Universitas Jenderal SoedirmanUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 3 Dec 2024 (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 goal of this study is to determine the effect of murottal and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia. This study also aims to evaluate whether these therapies can help reduce pain and influence the body's inflammatory response.
Main questions to be answered:
Can murottal or classical music reduce postoperative pain intensity in patients? Can the use of murottal or classical music lower the levels of interleukin 6, an inflammatory marker, in patients after lower extremity orthopedic surgery?
Participants will:
Listen to murottal or classical music during their lower extremity orthopedic surgery with spinal anesthesia.
Measure pain intensity and interleukin 6 levels before and after the intervention to assess the effect of the therapy.
Undergo routine checkups to ensure the safety and success of the therapy. This study aims to provide a deeper understanding of the use of non-pharmacological therapies such as murottal and classical music in managing pain and the inflammatory response in patients after orthopedic surgery.
Detailed description
This study aims to explore the impact of murottal (recitations of Islamic verses) and classical music on postoperative pain intensity and interleukin 6 levels in patients undergoing lower extremity orthopedic surgery with spinal anesthesia. Murottal and classical music are considered non-pharmacological interventions and have been suggested to have a calming effect that may help reduce pain and manage inflammation.
During the study, participants will be randomly assigned to receive either murottal, classical music, or standard postoperative care. Participants in the murottal group will listen to selected recitations durante operation, while participants in the classical music group will listen to classical music compositions.
Pain intensity will be assessed using a numeric rating scale (NRS) both before and after the intervention. Interleukin 6 levels, an inflammatory marker, will be measured using blood samples taken at the same intervals.
The goal is to determine whether these therapeutic interventions can help reduce pain and inflammation, as indicated by interleukin 6 levels, compared to standard care alone. Regular check-ups will be conducted to monitor safety and ensure the success of the therapy.
The findings of this study will help provide insights into the potential use of non-pharmacological interventions, such as murottal and classical music, in managing pain and inflammation in postoperative patients, with the potential to improve recovery outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a randomized, controlled trial with a parallel assignment study design. Participants will be randomly allocated to one of three groups: Murottal Group: Participants will listen to selected Islamic recitations (murottal) as a therapeutic intervention during their postoperative recovery. Classical Music Group: Participants will listen to selected classical music pieces to evaluate its impact on postoperative pain and inflammation. Standard Care Group: Participants will receive standard postoperative care without any additional therapeutic interventions. The goal is to assess and compare the effectiveness of murottal and classical music in reducing postoperative pain intensity and inflammation (measured by interleukin 6 levels), compared to the standard care. Randomization ensures unbiased distribution among the groups, and the parallel design enables simultaneous assessment of the interventions' effects in different groups.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Murottal Therapy | Experimental | Device: Murottal Therapy Intervention Name: Murottal (Islamic verse recitation)Arm 1: Murottal Therapy Intervention: Participants in this group will listen to selected recitations of Islamic verses (murottal) as a non-pharmacological intervention during their postoperative recovery. |
| Arm 2: Classical Music Therapy | Experimental | Device: Classical Music Therapy Intervention Name: Classical Music ListeningIntervention: Participants in this group will listen to selected classical music compositions during their recovery from lower extremity orthopedic surgery with spinal anesthesia. |
| Arm 3: Standard Care | Experimental | Other: Standard Care (in control arm)Participants in this group will receive standard postoperative care following their surgery, without any additional interventions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All Muslim patients who are scheduled for elective lower extremity orthopedic surgery during the study period.
- Patients aged 18 to 60 years.
- Patients who agree to participate in the study.
- Lower extremity orthopedic surgery (ORIF, OREF, and bone replacement) with a minimum surgery duration of 60 minutes.
Key exclusion criteria (6 listed)
- Patients with consciousness disorders
- Patients with neurological disorders
- Patients with cognitive disorders
- Patients with more than 3 spinal attempts
- Patients with hearing impairments
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 |
|---|---|---|
| Murottal Therapy Intervention Name: Murottal (Islamic verse recitation)To evaluate whether murottal recitations can reduce postoperative pain intensity and lower interleukin 6 levels, which are indicative of inflammation. | Device | Arm 1: Murottal Therapy |
| Classical Music Therapy Intervention Name: Classical Music ListeningTo evaluate the impact of classical music on reducing postoperative pain intensity and interleukin 6 levels in the body, thereby managing inflammation. | Device | Arm 2: Classical Music Therapy |
| Standard Care (in control arm)To serve as a control group no intervention | Other | Arm 3: Standard Care |
Primary outcome
Pain Intensity Postoperatively
Time frame: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
Primary Outcome Measure 1: Pain Intensity Postoperatively Description: This measure will assess the intensity of pain experienced by participants after surgery. Method of Measurement: Numeric Rating Scale (NRS), where participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Interleukin-6 (IL-6) Levels Postoperatively
Time frame: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)
Primary Outcome Measure 2: Interleukin-6 Levels Postoperatively Description: This measure will evaluate the levels of IL-6, a marker for inflammation, following surgery. Method of Measurement: Blood sample analysis, expressed in picograms per milliliter (pg/mL)
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 3 Dec 2024.
- Results publicationThe Effect of Music Therapy on Pain, Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: A Randomized Controlled Trial Ibrahim Karagoz. et al.
- The Effect of Perioperative Music on Medication Requirement and Hospital Length of Stay: A Meta-analysisLink 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Murottal Therapy Intervention Name: Murottal (Islamic verse recitation) and Classical Music Therapy Intervention Name: Classical Music Listening in people with Pain and Pain, Postoperative, run by Universitas Jenderal Soedirman at 1 site in Indonesia.
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 6 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: looking for participants now, as of the sponsor's last update on 3 Dec 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 Indonesia. 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?
Contact Guruh Perkasa, Doctor (+6285245883215, perkasaguruh90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Postoperatively (time frame: Timepoint: Pre-treatment (baseline, 10 minute before surgery) and post-treatment (30 minute post-surgery)). 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 NCT06713044, which also lists 1 linked publication.
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 3 Dec 2024.