Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-01-02 @ 3:51 AM
Study NCT ID:
NCT04485650
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Music in Intraoperative Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-20', 'size': 192338, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-13T04:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "In the study, 30 patients were assigned to the music group, 30 patients were assigned to the group that received sedation and 30 patients were assigned to a group that was not sedated, all occurred in a randomized controlled way.\n\nThe music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. Sedation (Dormicum) was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The patients in the non-sedated group were followed without any procedure (sedation and music)."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups', 'timeFrame': 'Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative', 'description': 'Measurement of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups'}, {'measure': 'Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups', 'timeFrame': 'Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative', 'description': 'Measurement of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups'}, {'measure': 'Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups', 'timeFrame': 'Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative', 'description': 'Measurement of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups'}, {'measure': 'Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups', 'timeFrame': 'Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative', 'description': 'Measurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups'}, {'measure': 'anxiety assessment 30 minutes before surgery', 'timeFrame': 'State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery', 'description': 'State- Trait Anxiety Scale was applied to all three groups in preoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)'}, {'measure': 'anxiety assessment 8 hours after surgery', 'timeFrame': 'State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery', 'description': 'State- Trait Anxiety Scale was applied to all three groups in postoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)'}, {'measure': 'pain assessment in the operating room', 'timeFrame': 'The pain was assessed at the end of the operation in 10 minutes with numerical pain scale', 'description': 'The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain'}, {'measure': 'Postoperative pain at 1 hours', 'timeFrame': 'The pain was assessed followed at 1 hours postoperative period with numerical pain scale', 'description': 'The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain.'}, {'measure': 'Postoperative pain at 8 hours', 'timeFrame': 'The pain was assessed followed at 8 hours postoperative period with numerical pain scale', 'description': 'The pain was assessed with numerical pain. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music therapy', 'perioperative care', 'postoperative pain', 'anxiety', 'total knee arthroplasty', 'vital signs', 'spinal aesthesia'], 'conditions': ['Music Therapy', 'Perioperative Care', 'Postoperative Pain', 'Anxiety', 'Total Knee Arthroplasty', 'Vital Signs', 'Spinal Anesthesia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Koc H, Erk G, Apaydin Y, Horasanli E, Yigitbasi B, Dikmen B. The Effects of Classical Turkish Music on Patients Undergoing Inguinal Hernia Repair under Epidural Anesthesia. Turk Anaesth Int Care. 2009;37:366-373.'}, {'type': 'BACKGROUND', 'citation': 'Sener EB, Koylu N, Ustun FE, Kocamanoglu S, Ozkan F. The effects of music, white noise and operating room noise on perioperative anxiety in patients under spinal anesthesia. European Journal Of Anaesthesiology (EJA). 2010;24:133'}, {'pmid': '22290677', 'type': 'BACKGROUND', 'citation': 'Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.'}, {'type': 'BACKGROUND', 'citation': 'Bansal P, Kharrod U, Sanwatsarkar S, Patel H, Kamat H. The Effect Of Music Therapy On Sedative Requirements And Haemodynamic Parameters In Patients Under Spinal Anaesthesia; A Prospective Study. Journal Of Clinical And Diagnostic Research. 2010;4:2782-2789.'}, {'pmid': '26365452', 'type': 'BACKGROUND', 'citation': 'Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.'}, {'pmid': '11382277', 'type': 'BACKGROUND', 'citation': 'Allen K, Golden LH, Izzo JL Jr, Ching MI, Forrest A, Niles CR, Niswander PR, Barlow JC. Normalization of hypertensive responses during ambulatory surgical stress by perioperative music. Psychosom Med. 2001 May-Jun;63(3):487-92. doi: 10.1097/00006842-200105000-00019.'}, {'pmid': '24731896', 'type': 'BACKGROUND', 'citation': 'Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.'}, {'pmid': '25793222', 'type': 'BACKGROUND', 'citation': 'Komurcu E, Kiraz HA, Kaymaz B, Golge UH, Nusran G, Goksel F, Sahin H, Omur D, Hanci V. The effect of intraoperative sounds of saw and hammer on psychological condition in patients with total knee arthroplasty: prospective randomized study. ScientificWorldJournal. 2015;2015:690569. doi: 10.1155/2015/690569. Epub 2015 Feb 22.'}, {'type': 'BACKGROUND', 'citation': 'Sarkar D, Chakraborty K, Bhadra B, Ghorai TK, Singh R, Mandal U. Effects of music on patients undergoing orthopaedic surgery under spinal anaesthesia. IOSR Journal of Dental and Medical Sciences. 2015;14:2279-2861.'}, {'pmid': '16741859', 'type': 'BACKGROUND', 'citation': 'Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.'}, {'pmid': '20888947', 'type': 'BACKGROUND', 'citation': 'Bailey L. Strategies for decreasing patient anxiety in the perioperative setting. AORN J. 2010 Oct;92(4):445-57; quiz 458-60. doi: 10.1016/j.aorn.2010.04.017.'}, {'pmid': '12374706', 'type': 'BACKGROUND', 'citation': 'Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.'}, {'pmid': '16466484', 'type': 'BACKGROUND', 'citation': 'Carr E, Brockbank K, Allen S, Strike P. Patterns and frequency of anxiety in women undergoing gynaecological surgery. J Clin Nurs. 2006 Mar;15(3):341-52. doi: 10.1111/j.1365-2702.2006.01285.x.'}, {'type': 'BACKGROUND', 'citation': 'Gursoy A A. Anxiety Levels of Preoperative Patients and Determining the Factors That May Cause Anxiety. Journal of Nursing Research. 2001;1:23-29.'}, {'type': 'BACKGROUND', 'citation': 'Turhan Y, Avci R, Ozcengiz D. The Relationship Between Preoperative And Postoperative Anxiety, And Patient Satisfaction In Preparation For Elective Surgery. Journal of Anesthesia. 2012;20:27-33'}, {'pmid': '17352896', 'type': 'BACKGROUND', 'citation': 'Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.'}, {'type': 'BACKGROUND', 'citation': 'Yilmaz E, Aydin E. The Effect of Pre and Postoperative Anxiety in Quality of Recovery in Patients Undergoing Surgery. Fırat Health Services Journal. 2013;8:79-95.'}, {'type': 'BACKGROUND', 'citation': 'Eti Aslan F. The assessment methods of pain. Journal of Cumhuriyet University School of Nursing. 2002;6:9-16.'}, {'pmid': '8315037', 'type': 'BACKGROUND', 'citation': 'Shek DT. The Chinese version of the State-Trait Anxiety Inventory: its relationship to different measures of psychological well-being. J Clin Psychol. 1993 May;49(3):349-58. doi: 10.1002/1097-4679(199305)49:33.0.co;2-j.'}, {'pmid': '11574356', 'type': 'BACKGROUND', 'citation': 'Lepage C, Drolet P, Girard M, Grenier Y, DeGagne R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. doi: 10.1097/00000539-200110000-00022.'}, {'pmid': '28336024', 'type': 'BACKGROUND', 'citation': 'Zhu NN, Xu PP, Lei TT, Sun T, Chan SW. Postoperative Pain Self-Management Behavior in Patients Who Underwent Total Knee or Hip Arthroplasty. AORN J. 2017 Apr;105(4):355-364. doi: 10.1016/j.aorn.2017.02.001.'}, {'pmid': '25754254', 'type': 'BACKGROUND', 'citation': 'Chen HJ, Chen TY, Huang CY, Hsieh YM, Lai HL. Effects of music on psychophysiological responses and opioid dosage in patients undergoing total knee replacement surgery. Jpn J Nurs Sci. 2015 Oct;12(4):309-19. doi: 10.1111/jjns.12070. Epub 2015 Mar 9.'}, {'pmid': '16699359', 'type': 'BACKGROUND', 'citation': 'Sendelbach SE, Halm MA, Doran KA, Miller EH, Gaillard P. Effects of music therapy on physiological and psychological outcomes for patients undergoing cardiac surgery. J Cardiovasc Nurs. 2006 May-Jun;21(3):194-200. doi: 10.1097/00005082-200605000-00007.'}, {'pmid': '29784556', 'type': 'BACKGROUND', 'citation': 'Ozdemir U, Tasci S, Yildizhan E, Aslan S, Eser B. The Effect of Classical Turkish Music on Pain Severity and Anxiety Levels in Patients Undergoing Bone Marrow Aspiration and Biopsy. Pain Manag Nurs. 2019 Feb;20(1):82-87. doi: 10.1016/j.pmn.2018.04.009. Epub 2018 May 18.'}, {'pmid': '25078946', 'type': 'BACKGROUND', 'citation': 'Labrague LJ, McEnroe-Petitte DM. Influence of Music on Preoperative Anxiety and Physiologic Parameters in Women Undergoing Gynecologic Surgery. Clin Nurs Res. 2016 Apr;25(2):157-73. doi: 10.1177/1054773814544168. Epub 2014 Jul 30.'}, {'pmid': '23953858', 'type': 'BACKGROUND', 'citation': 'Jimenez-Jimenez M, Garcia-Escalona A, Martin-Lopez A, De Vera-Vera R, De Haro J. Intraoperative stress and anxiety reduction with music therapy: a controlled randomized clinical trial of efficacy and safety. J Vasc Nurs. 2013 Sep;31(3):101-6. doi: 10.1016/j.jvn.2012.10.002.'}]}, 'descriptionModule': {'briefSummary': "Background and Aims: Music therapy has a wide range of uses in health care practice. The aim of this study was to investigate the effects of intraoperative music played during spinal anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and anxiety status.\n\nMethods: The study was performed in an operating room with a total of 90 patients, of whom 30 were in the music group, 30 were in the control group and 30 were in the sedated group. The ethics committee's approval, institutional permission, and the study participants' written informed consent were obtained. Data were collected using patient information and intraoperative observation form for vital signs as well as through the Visual Analog Scale and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and postoperative vital signs and postoperative pain and anxiety of all groups were analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients that had an orthopedic operation\n* The patients who took spinal anesthesia\n* able to understand, read and speak Turkish, so they may complete the informed consent and questionaires\n* Aged 18 or older\n* Have a Body Mass Index (BMI) \\<40\n* ASA (American Society of Anaesthesiologists) I-II-III statuses.\n\nExclusion Criteria:\n\n* Patients with vision and hearing problems and inability to complete questionnaires,\n* The patients not have psychiatric disease history and psychiatric drug use,\n* The patients not have diseases that could be evaluated as severe (such as heart, kidney, liver failure)\n* The patients not underwent emergency surgeries'}, 'identificationModule': {'nctId': 'NCT04485650', 'briefTitle': 'Effect of Music in Intraoperative Period', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AIBU-AML-UY-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music group', 'description': 'The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. The number of participants:30', 'interventionNames': ['Other: music therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sedated group', 'description': "Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30", 'interventionNames': ['Other: sedated group']}, {'type': 'OTHER', 'label': 'Non-sedated group', 'description': 'The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30', 'interventionNames': ['Other: non-sedated group']}], 'interventions': [{'name': 'music therapy', 'type': 'OTHER', 'description': 'The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group.', 'armGroupLabels': ['Music group']}, {'name': 'sedated group', 'type': 'OTHER', 'description': "Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30", 'armGroupLabels': ['Sedated group']}, {'name': 'non-sedated group', 'type': 'OTHER', 'description': 'The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30', 'armGroupLabels': ['Non-sedated group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Faculty of health sciences', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'ümmühan yiğit, msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'research assistant'}, {'name': 'arzu ilçe, proffesor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of health science of dean'}, {'name': 'ibrahim karagöz, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'anesthesiology and reanimation doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'when the planned number of participants was reached, the data were coded in a statistical program and shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}