Music TherapyNCT06970431
Therapy on Perioperative Anxiety and Pain in Patients
A study testing eoperative Education + Intraoperative Music Therapy Arm and Preoperative Education Alone Arm in people with Music Therapy and Anxiety, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial summary
This study aims to explore the effects of preoperative education combined with intraoperative music therapy on perioperative anxiety and pain in patients undergoing elective cesarean section. The study subjects were patients scheduled for cesarean section under combined spinal - epidural anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Music Therapy, Anxiety, Health Education
- What is being tested?
- eoperative Education + Intraoperative Music Therapy Arm and Preoperative Education Alone Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 10 Jan 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- History of pregnancy-related complications severe pregnancy complications (e.g., preeclampsia, gestational diabetes mellitus) Severe mental illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients
This study aims to explore the effects of preoperative education combined with intraoperative music therapy on perioperative anxiety and pain in patients undergoing elective cesarean section. The study subjects were patients scheduled for cesarean section under combined spinal - epidural anesthesia. A prospective study design with random grouping was adopted. Through systematic preoperative education and intraoperative music intervention, multi - dimensional evaluations were carried out to analyze the effects of preoperative education combined with intraoperative music therapy on the relief of perioperative anxiety, pain and shivering in patients, as well as its impact on postoperative recovery and nursing satisfaction.
Read the detailed description
- Research Methods A prospective randomized controlled trial design will be used. Eligible elective cesarean patients will be randomly assigned to an experimental group (preoperative education + intraoperative music therapy) or a control group (routine preoperative education only).
- Preoperative Health Education Conducted by dedicated nurses 1 day before surgery, covering surgical procedures, precautions, anesthesia, and postoperative recovery.
- Intraoperative Music Therapy Experimental group: Headphones fitted 1 hour preoperatively at 45-55 decibels, playing personalized or pre-screened music continuously during surgery and for 30 minutes postoperatively. Intervention timing: Headphone adaptation and volume adjustment 1 hour preoperatively; continuous playback during surgery; 30-minute playback postoperatively to reduce anxiety and discomfort. Executors: Preoperative education by specialized nurses; music therapy by trained operating room nurses to ensure equipment and volume stability.
- Data Collection Assessments at specified time points using standardized tools: Anxiety: GAD-7 scale (preoperative, 6h, 12h, 24h postoperatively). Pain: VAS scale (preoperative, 6h, 12h, 24h postoperatively). Shivering index: Cold Shivering Index Scale (preoperative, before headphone use, at discharge from the operating room). Postoperative complications: Wound infection, urinary retention, hemorrhage, heart failure, or pulmonary embolism. Recovery indicators: Ambulation time, anal exhaust time, lactation time, hospital stay. Satisfaction surveys: Nursing and anesthesia satisfaction via questionnaires 24h postoperatively.
- Study Population
Inclusion criteria:
18-40 years old, singleton pregnancy, eligible for elective cesarean section. No severe pregnancy complications (e.g., preeclampsia, gestational diabetes). Able to provide informed consent and complete follow-ups.
Exclusion criteria:
Complications or diseases affecting study outcomes. Severe mental illness preventing protocol understanding. Refusal to participate or incomplete follow-ups. Allergy to music/headphones. II. Technical Route Literature review \& protocol design: Develop the study plan and obtain ethical approval.
Patient recruitment \& randomization: Enroll patients per criteria; use random number tables for grouping.
Intervention \& data recording: Standardized interventions by the research team; regular data verification.
Data analysis \& reporting: Statistical analysis to compare group differences; summarize findings and draft reports.
III. Feasibility Analysis Sample size: Estimated 64 patients per group (140 total, including 10% dropout rate) based on anxiety score differences and literature.
Ethical feasibility: Informed consent obtained; complies with ethical review requirements.
Technical feasibility: Hospital equipped with nursing tools (headphones, assessment scales) and a skilled team.
Resource feasibility: Reasonable budget and 10-month timeline ensure timely data collection, analysis, and reporting.
- Conditions
- Music Therapy, Anxiety, Health Education
- Being tested
- eoperative Education + Intraoperative Music Therapy Arm, Preoperative Education Alone Arm
- Medical subject headings
- Anxiety Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eoperative Education + Intraoperative Music Therapy ArmOther
The experimental group implemented standardized preoperative education one day before the operation (covering knowledge such as the surgical procedure), headphone fitting one hour before the operation (with a volume of 45-55 decibels), and music therapy throughout the operation and for 30 minutes after the operation (parturients can choose personalized music). Full-time nurses were responsible for the preoperative education, and trained operating room nurses implemented the music therapy. Meanwhile, data such as anxiety scores, pain scores, shivering index, postoperative complications, postoperative recovery status, and satisfaction surveys were collected at multiple time points through standardized tools.
Preoperative Education Alone ArmOther
The control group received the same standardized preoperative education by full-time nurses one day before the operation, covering surgical procedures, precautions, anesthesia, and postoperative recovery.
Data were collected at multiple time points using standardized tools, including anxiety scores (before and 6, 12, 24 h after surgery via GAD-7), pain scores (before and 6, 12, 24 h after via VAS), shivering index (before surgery, before wearing headphones, when leaving OR), postoperative complications (wound infection, urinary retention, etc.), postoperative recovery indicators (time to get out of bed, anal exhaust, breastfeeding start, hospital stay), and satisfaction surveys (24 h after surgery).
Importantly, the control group had no music therapy intervention before, during, or after surgery.
| Study group | Role | What they receive |
|---|---|---|
| reoperative Education + Intraoperative Music Therapy Arm | Experimental | The standardized preoperative education and the individualized music therapy during the operation are implemented jointly, and the patients' perioperative anxiety values, pain scores, shivering index, etc. are collected. Receives: Other: eoperative Education + Intraoperative Music Therapy Arm |
| Preoperative Education Alone Arm | Active comparator | The control group only received standardized preoperative education. Receives: Other: Preoperative Education Alone Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety score
Before the operation and at 6 hours, 12 hours, and 24 hours after the operation, the Generalized Anxiety Disorder 7-item scale (GAD-7 scale) is used.The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a widely used tool to assess the severity of generalized anxiety symptoms.
Score Range: Scores range from 0 to 21, with each of the 7 items rated on a 4-point scale (0 = "Not at all" to 3 = "Nearly every day").
Interpretation: Higher scores indicate worse outcomes, reflecting more severe anxiety symptoms. Specifically:
0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety This scale helps clinicians and researchers quantify anxiety levels, with higher scores signifying greater distress and functional impairment.
Measured: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
pain score
The Visual Analogue Scale (VAS) is used to assess pain intensity. Full Name: Visual Analogue Scale Score Range: Scores range from 0 to 10, where 0 = "No pain" and 10 = "Worst pain imaginable".
Interpretation: Higher scores indicate worse outcomes, reflecting more severe pain.
Assessment Time Points: Pain is evaluated at preoperative baseline, and at 6 hours, 12 hours, and 24 hours postoperatively to measure acute pain changes during the perioperative period.
This validated single-item scale allows patients to rate their pain on a continuous numeric scale, providing a straightforward method to quantify pain severity. Clear time-specific assessments (preoperative and postoperative time points) ensure standardized data collection for comparing intervention effects between groups.
Measured: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
Secondary outcomes (2)
shivering index
The Cold Shivering Index Scale (CSIS) is used to evaluate the severity of intraoperative shivering. Scores range from 0 to 4, with specific criteria:
0 = No shivering
- = Faint shivering (visible muscle contraction without body movement)
- = Mild shivering (mild, controlled body movement)
- = Moderate shivering (obvious body tremors affecting the surgical field)
- = Severe shivering (uncontrollable whole-body shaking interfering with surgery).
Higher scores indicate worse outcomes, reflecting more severe shivering and decreased patient comfort during surgery.
Measured: baseline (before any intervention is initiated), Immediately After Birth,Perioperative
Record of postoperative complications
Such as wound infection, urinary retention, bleeding, heart failure or pulmonary embolism, etc.
Measured: Complications during hospitalization(assessed up to 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Feb 2025
- Primary completion1 Jun 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Na Li, MD, Study director, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970431
- Sponsor's protocol ID
- MCHH_012
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients
- ClinicalTrials.gov ID
- NCT06970431
- Acronym / sponsor ID
- MCHH_012
- Conditions
- Music Therapy, Anxiety, Health Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 14 May 2025 (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.
This study aims to explore the effects of preoperative education combined with intraoperative music therapy on perioperative anxiety and pain in patients undergoing elective cesarean section. The study subjects were patients scheduled for cesarean section under combined spinal - epidural anesthesia. A prospective study design with random grouping was adopted. Through systematic preoperative education and intraoperative music intervention, multi - dimensional evaluations were carried out to analyze the effects of preoperative education combined with intraoperative music therapy on the relief of perioperative anxiety, pain and shivering in patients, as well as its impact on postoperative recovery and nursing satisfaction.
Detailed description
- Research Methods A prospective randomized controlled trial design will be used. Eligible elective cesarean patients will be randomly assigned to an experimental group (preoperative education + intraoperative music therapy) or a control group (routine preoperative education only).
- Preoperative Health Education Conducted by dedicated nurses 1 day before surgery, covering surgical procedures, precautions, anesthesia, and postoperative recovery.
- Intraoperative Music Therapy Experimental group: Headphones fitted 1 hour preoperatively at 45-55 decibels, playing personalized or pre-screened music continuously during surgery and for 30 minutes postoperatively. Intervention timing: Headphone adaptation and volume adjustment 1 hour preoperatively; continuous playback during surgery; 30-minute playback postoperatively to reduce anxiety and discomfort. Executors: Preoperative education by specialized nurses; music therapy by trained operating room nurses to ensure equipment and volume stability.
- Data Collection Assessments at specified time points using standardized tools: Anxiety: GAD-7 scale (preoperative, 6h, 12h, 24h postoperatively). Pain: VAS scale (preoperative, 6h, 12h, 24h postoperatively). Shivering index: Cold Shivering Index Scale (preoperative, before headphone use, at discharge from the operating room). Postoperative complications: Wound infection, urinary retention, hemorrhage, heart failure, or pulmonary embolism. Recovery indicators: Ambulation time, anal exhaust time, lactation time, hospital stay. Satisfaction surveys: Nursing and anesthesia satisfaction via questionnaires 24h postoperatively.
- Study Population
Inclusion criteria:
18-40 years old, singleton pregnancy, eligible for elective cesarean section. No severe pregnancy complications (e.g., preeclampsia, gestational diabetes). Able to provide informed consent and complete follow-ups.
Exclusion criteria:
Complications or diseases affecting study outcomes. Severe mental illness preventing protocol understanding. Refusal to participate or incomplete follow-ups. Allergy to music/headphones. II. Technical Route Literature review \& protocol design: Develop the study plan and obtain ethical approval.
Patient recruitment \& randomization: Enroll patients per criteria; use random number tables for grouping.
Intervention \& data recording: Standardized interventions by the research team; regular data verification.
Data analysis \& reporting: Statistical analysis to compare group differences; summarize findings and draft reports.
III. Feasibility Analysis Sample size: Estimated 64 patients per group (140 total, including 10% dropout rate) based on anxiety score differences and literature.
Ethical feasibility: Informed consent obtained; complies with ethical review requirements.
Technical feasibility: Hospital equipped with nursing tools (headphones, assessment scales) and a skilled team.
Resource feasibility: Reasonable budget and 10-month timeline ensure timely data collection, analysis, and reporting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reoperative Education + Intraoperative Music Therapy Arm | Experimental | Other: eoperative Education + Intraoperative Music Therapy ArmThe standardized preoperative education and the individualized music therapy during the operation are implemented jointly, and the patients' perioperative anxiety values, pain scores, shivering index, etc. are collected. |
| Preoperative Education Alone Arm | Active comparator | Other: Preoperative Education Alone ArmThe control group only received standardized preoperative education. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- History of pregnancy-related complications severe pregnancy complications (e.g., preeclampsia, gestational diabetes mellitus) Severe mental illness
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 |
|---|---|---|
| eoperative Education + Intraoperative Music Therapy ArmThe experimental group implemented standardized preoperative education one day before the operation (covering knowledge such as the surgical procedure), headphone fitting one hour before the operation (with a volume of 45-55 decibels), and music therapy throughout the operation and for 30 minutes after the operation (parturients can choose personalized music). Full-time nurses were responsible for the preoperative education, and trained operating room nurses implemented the music therapy. Meanwhile, data such as anxiety scores, pain scores, shivering index, postoperative complications, postoperative recovery status, and satisfaction surveys were collected at multiple time points through standardized tools. | Other | reoperative Education + Intraoperative Music Therapy Arm |
| Preoperative Education Alone ArmThe control group received the same standardized preoperative education by full-time nurses one day before the operation, covering surgical procedures, precautions, anesthesia, and postoperative recovery. Data were collected at multiple time points using standardized tools, including anxiety scores (before and 6, 12, 24 h after surgery via GAD-7), pain scores (before and 6, 12, 24 h after via VAS), shivering index (before surgery, before wearing headphones, when leaving OR), postoperative complications (wound infection, urinary retention, etc.), postoperative recovery indicators (time to get out of bed, anal exhaust, breastfeeding start, hospital stay), and satisfaction surveys (24 h after surgery). Importantly, the control group had no music therapy intervention before, during, or after surgery. | Other | Preoperative Education Alone Arm |
Primary outcome
anxiety score
Time frame: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
Before the operation and at 6 hours, 12 hours, and 24 hours after the operation, the Generalized Anxiety Disorder 7-item scale (GAD-7 scale) is used.The Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a widely used tool to assess the severity of generalized anxiety symptoms. Score Range: Scores range from 0 to 21, with each of the 7 items rated on a 4-point scale (0 = "Not at all" to 3 = "Nearly every day"). Interpretation: Higher scores indicate worse outcomes, reflecting more severe anxiety symptoms. Specifically: 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety This scale helps clinicians and researchers quantify anxiety levels, with higher scores signifying greater distress and functional impairment.
pain score
Time frame: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively
The Visual Analogue Scale (VAS) is used to assess pain intensity. Full Name: Visual Analogue Scale Score Range: Scores range from 0 to 10, where 0 = "No pain" and 10 = "Worst pain imaginable". Interpretation: Higher scores indicate worse outcomes, reflecting more severe pain. Assessment Time Points: Pain is evaluated at preoperative baseline, and at 6 hours, 12 hours, and 24 hours postoperatively to measure acute pain changes during the perioperative period. This validated single-item scale allows patients to rate their pain on a continuous numeric scale, providing a straightforward method to quantify pain severity. Clear time-specific assessments (preoperative and postoperative time points) ensure standardized data collection for comparing intervention effects between groups.
2 secondary outcomes
shivering index
Time frame: baseline (before any intervention is initiated), Immediately After Birth,Perioperative
Record of postoperative complications
Time frame: Complications during hospitalization(assessed up to 5 days)
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 14 May 2025.
- 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.
Na Li, MD study director
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eoperative Education + Intraoperative Music Therapy Arm and Preoperative Education Alone Arm in people with Music Therapy and Anxiety, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
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 0 inclusion and 1 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 14 May 2025. 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 China. 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 Na Li, MD (+862763490107, lina@hbfy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety score (time frame: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively). 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?
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 14 May 2025.