Methodology
Study setting
This study was conducted at the Department of Ophthalmology of the UNTH, Ituku Ozalla, located 21 km from Enugu metropolis. UNTH, Ituku Ozalla is in Enugu West Senatorial Zone, which includes some parts of Enugu metropolis, while Enugu is the capital of Enugu State. Its longitude and latitude are 7.4619⁰ E and 6.3014⁰ N, respectively. In the 2006 census, the Enugu metropolitan area was estimated to have a population of 722 664, who are predominantly Christians. The ophthalmology department started in 1971 as a subdepartment of surgery, with the staff currently comprising of 7 optometrists, 14 residents, 10 nurses and 16 consultants. It also has a fully dedicated functional operating theatre with three suites. Ocular procedures are performed on a daily basis by different teams, running Mondays through Fridays and averaging 20 ocular surgeries or more weekly. It has various subspecialties at various levels of development namely, Public Health Ophthalmology, Glaucoma, Paediatrics Ophthalmology, Vitreo-retina, Low vision, Cornea and Anterior segment, Oculo-plastic and Neuro-ophthalmology. Cataract surgery, which is one of the most common ocular procedures done in UNTH, is carried out mainly with regional anaesthesia, while very few adults and children are done under general anaesthesia. On average, about 15 cataract surgeries are performed weekly
Study design
This was a randomised interventional study of individuals aged 50 years and above who were scheduled for and undergoing cataract surgery, with music and regional anaesthesia, matched with individuals 50 years and above scheduled for and undergoing cataract surgery without music but also with regional anaesthesia in the Department of Ophthalmology Operating Theatre, UNTH, Ituku Ozalla, Enugu. Study participants were excluded from this study if they had cataract other than age-related and younger than 50 years of age, major ocular morbidity, had uncorrected hearing problems and declined to participate, Patients whose age were equal to or greater than 50 years, scheduled for cataract surgery at UNTH Ituku Ozalla under regional anaesthesia and consented to participate were enrolled into the study. A total of 98 participants were selected using a systematic random sampling method. Study participants were assigned into two groups (ie, group A, those that underwent surgery with music and group B, those that underwent surgery without music).
Sampling technique
Subjects that came for uncomplicated cataract surgery were recruited in the outpatient clinics following thorough clinical evaluations which included a systemic and ocular examinations with satisfaction of eligibility criteria for the study. Approximately 15 patients were recruited weekly for this study. The patients were fully educated on the study, the surgery and the music method being used, and a written informed consent was obtained. Consenting individuals were enrolled based on the inclusion and exclusion criteria. The participants were randomised into two different study groups using systematic sampling method. This randomisation was done by the research assistant and the researcher was blinded to the groups. The participants were distributed to the groups as they presented starting with the first participant to present. The first participant enrolled became a member of the group A (odd numbers) and the next participant enrolled became a member of the group B (even numbers). Placement into these two groups continued in the same manner alternately as they were enrolled. At the end of each day, the last group of participants enrolled were noted and the next day the other group of participants started the day’s enrolment. For example, if five participants were enrolled in a day, with the fifth participant falling into the group A category, the next day subsequently started with the group B participants being enrolled first. Odd numbers (group A) were for individuals that underwent surgery while they listened to music and even numbers (group B) were for individuals that underwent surgery without music. Every patient used a particular earphone assigned to him/her in order to maintain sterility. All the measured indices were recorded in a data sheet assigned to each patient.
Sample size determination
The minimum sample size (n) for this study was determined using the formula for comparison between two groups/proportions. Sample size calculation was based on prevalence and results of similar studies among preoperative anxiety studies in cataract patients.11
Zα=the standard normal variate at 95% CI if p<0.05 which equals 1.96.
Zβ=power of the study at 80% from Z-table which equals 0.842.
P1=the proportion of subjects who used preoperative and intraoperative music – 0.6454.11
P2=the proportion of subjects who did not use preoperative and intraoperative music – 0.3546.11
(P1−P2)2=difference in independent proportions which equals (0.6454–0.3546)2=0.0846.
The minimum sample size was adjusted based on the probability of a non-response rate of 10% with the formula;
Where n=minimum sample size which equals 42,
r=10% or 0.1.
Thus, sample size for the two groups=47×2=94,
n=94.
Increasing n by 10% to leave room for errors which involves any factor that would make any participant not to show up or have his/her surgery suddenly cancelled=94+ (10% of 94)
26=94+10,
n=104,
Study instruments
The Hamilton State-Trait Anxiety Inventory (STAI): This questionnaire distinguishes between state anxiety (a temporary condition experienced in specific situations) and trait anxiety (a general tendency to perceive situations as threatening).12 It was developed originally to study and treat anxiety in adults, although now it can be used for screening anxiety disorders. This questionnaire was developed by Spielberger in 1968 and has been in use up until today. The questionnaire was designed to be self-administered; however, it can be interviewer administered if necessary. There is no time limit, however approximate time ranges from 4 to 10 min depending on the educational level of the participant. The questionnaire consists of 40 questions, divided into 20 questions for each form and each STAI item is given a weighted score of 1–4. A rating of 4 indicates the presence of a high level of anxiety for 10 S-Anxiety items and 11 T-Anxiety items. A high rating indicates the absence of anxiety for the remaining 10 S-Anxiety items and 9 T-Anxiety items. The two forms of anxiety are separated in the inventory, and both are given their own 20 separate questions. The scoring weights for the anxiety-present items are the same as the blackened numbers on the test form. The scoring weights for the anxiety-absent items are reversed, that is, responses marked 1, 2, 3 or 4 are scored 4, 3, 2 or 1, respectively. This has been validated and used in Nigeria in 2009 in a study aimed at checking psychological states of amputees.13 The clinical cut-off for anxiety is a score of 41 and above. This questionnaire was interviewer administered for the purposes of this research.
Earphones: VectorStock earphones were used to listen to the music played by the mp3 (MPEG audio layer 111). The subject applied the earpiece to him/herself in order to get a more comfortable placement. Each patient was given a new earphone to wear in order to prevent infections.
Mp3 player: The 2019 New Stylish Mirror Portable MP3 Player, Mini Clip MP3 Player Walkman Sport Mp3 with dimension Approximately 4.3 cm × 2.9 cm × 1.5 cm played the chosen music. Patient’s preferred music was used and volume was set at the third volume click from the zero mark.
Study procedure
On admission, the STAI questionnaire was filled by the study participants, which served as the baseline indices. On entrance into the preoperative room, the STAI questionnaire was filled for the second time. Earphones were put in place and preferred music was played for the group A for 5 min, after which the STAI questionnaire was filled again for the third time. The music was played with the aid of a disposable earpiece. Same process was repeated for the group B except for that music was not played after the earphones was put in place (online supplemental files 1; 2).
Data analysis
Data obtained from the study was first entered in the Microsoft Excel spread sheet of the computer, cleaned and coded. Data were subsequently imported into the SPSS (Statistical Package for Social Sciences) V.20 software for analysis. Tables and charts were used where appropriate. Categorical variables were compared using the χ2 test and its variants. Student’s t-test was used for continuous variables such as comparing preintervention and postintervention means of both groups. Analysis of variance was used in comparing means with more than two variables. P value of less than 0.05 was considered as statistically significant.
Ethical considerations
This research was conducted according to the tenets of the National health research Ethics and the department of health. Permission was sought from the consultants operating in the theatre where the study was carried out and also from the Head of Department of Ophthalmology. A written informed consent was obtained from the study participants. This study also adhered to the declaration 32 of Helsinki which states that the participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. Participants were told of their right to decline or withdraw from the study at any point without any consequences. Data collected for this research was stored in password protected computers and participants names were made anonymous. Notably, the participants were told that their data will not be accessible to a third party without their consent. Interviews and screening were carried out privately, and the research was non-invasive and did not inflict any form of bodily or emotional harm on the participants.