Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Closed Fracture of Shaft of Femur
  • Postoperative Anxiety
  • Postoperative Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The design of this study is a randomised controlled trial based on the CONSORT 2010 flow diagram. Patients warded at the orthopaedics wards in two government hospitals, who have been hospitalized following a closed midshaft femur fracture and planned for surgery. Patients who fulfill the inclusion criteria will be invited to participate in this study. Recruitment to participate is based on voluntary and they will be given the patient information sheet, written informed consent and briefed on the protocol of the study. The patients will be randomised either in the intervention or control group by selecting an opaque envelope.Masking: Double (Participant, Investigator)Masking Description: To ensure non-bias during the randomization, both the researcher and the patient will be masked and this procedure will be carried out by a trained research assistant.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

The administration of music as an adjuvant to medicine during the recovery after surgery especially should be further explored by examining the physiological parameters of what takes place in the human body when pain and anxiety are present. Permision to conduct this study have been granted by the N...

The administration of music as an adjuvant to medicine during the recovery after surgery especially should be further explored by examining the physiological parameters of what takes place in the human body when pain and anxiety are present. Permision to conduct this study have been granted by the National Medical Research Registry of the Ministry of Health of Malaysia, the Medical Research Ethics Committee from Universiti Putra Malaysia as well as University of Malaya. During the intervention, the standard course of treatment by the attending physician will not be interrupted. The patients have the liberty to drop out from the study at any point of time without any repercussion. The Standard Operating Procedure for all information obtained in this study will be kept and handled in a confidential manner, and destroyed thereafter analysis in accordance with applicable laws and regulations by the Ethics Committee of Universiti Putra Malaysia. When publishing or presenting the study results, the identity of the patients will not be revealed. Only individuals involved in this study such as the researchers, attending physicians, qualified monitors and auditors, Universiti Putra Malaysia or its affiliates and governmental or regulatory authorities can access the data from this study. The sample size assessment to specify the number of participants was necessary to demonstrate an effect. Data collected will be coded and transferred into the SPSS (Version 25.0) for analyses. Appropriate tests will be selected based on whether the data is normally distributed or not. P-value will be set to 0.05 to indicate level of significance with confidence interval of 95%. Depending on the distribution of the data, the appropriate statistical analysis will be determined to compare pre- and post-test results. Descriptive statistical analysis will be performed on all study variable at each time point. Spearman correlation coefficient will be used to determine the correlation of the main study outcomes, which are pain and anxiety. Inferential statistical analysis such as t-test and Chi-square will be used to determine the existence of significance differences in demography of the patients. Paired t-test will be used to differentiate the results between the pre- and post-test for the pain and anxiety scores. A normality test, Kolmogorov-Smirnov test, will be performed to look at the distribution of the data. For comparison between the experimental and control group, the Mann-Whitney U and one-way analysis of variance (ANOVA) tests will be performed to using the median and mean scores from both groups and as well the dosage of analgesia prescribed to both groups. Missing information will be recorded but not included in the data analysis. Data collected, processed and churned for results and reported by the researcher will be closely monitored by a certified medical statistician who has been appointed to advice the research team. The supervisory committee will retain all rights to advise on the development of the research.

Tracking Information

NCT #
NCT04175574
Collaborators
University of Malaya
Investigators
Not Provided