Affective Slider (Betella \& Verschure, 2016), consists of two single item visual analogue scales. Scores for each are presented as a value from 0 to 100 with higher scores indicating greater pleasure (VAS-Valence) and arousal (VAS-Arousal).
Positive and Negative Affect Schedule (Watson et al., 1988). Positive and negative affect subscales were created by summing the scores of positive and negative adjectives respectively. For each sub scale, minimum score = 10, maximum score = 50 with higher scores indicating greater positive and negative affect respectively.
Pictorial scale of positive aff
Post-Intervention VAS-Valence
Group
Value
95% CI
Experimental
87.4
± 15.7
Active Control
79.8
± 20.8
Post-Intervention VAS-Arousal
Group
Value
95% CI
Experimental
83.7
± 16.8
Active Control
79.8
± 20.3
Post-Intervention Pictorial Scale
Group
Value
95% CI
Experimental
4.7
± 1.1
Active Control
4.0
± 1.5
Post-Intervention PANAS Positive Affect
Group
Value
95% CI
Experimental
35.0
± 8.4
Active Control
35.0
± 7.6
Post-Intervention PANAS Negative Affect
Group
Value
95% CI
Experimental
11.1
± 3.0
Active Control
11.4
± 2.3
Pre-Intervention VAS-Valence
Group
Value
95% CI
Experimental
79.5
± 19.2
Active Control
80.5
± 18.1
Pre-Intervention VAS-Arousal
Group
Value
95% CI
Experimental
79.9
± 19.0
Active Control
80.9
± 20.1
Pre-Intervention Pictorial
Group
Value
95% CI
Experimental
3.7
± 1.5
Active Control
4.0
± 1.5
RecruitmentSecondary· Baseline
Recruitment rates to inform a future definitive trial
Secretory IgA ResponseSecondary· Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).
Secretory IgA levels measured in saliva samples via ELISA. This is a non-specific measure of immunological response
Pre-Intervention Flow Rate
Group
Value
95% CI
Experimental
81.0
± 76.4
Active Control
94.1
± 94.2
Post-Intervention Flow Rate
Group
Value
95% CI
Experimental
116.7
± 107.5
Active Control
144.7
± 142.5
Vaccine Specific IgG ResponseSecondary· 4 weeks (post-vaccination), 16 Weeks (post-vaccination)
IgG levels against the 4 vaccine strains measured via ELISA.
Values represent equivalent ug/ml based on diluted sample absorbance value interpolation against a standard IgG curve, multiplied by the serum dilution score (i.e., 4000).
4 Weeks Post-Vaccination A/Michigan
Group
Value
95% CI
Experimental
243.28
± 134.52
Active Control
208.81
± 122.42
4 Weeks Post-Vaccination A/Hong-Kind
Group
Value
95% CI
Experimental
301.68
± 138.88
Active Control
284.96
± 138.64
4 Weeks Post-Vaccination B/Brisbane
Group
Value
95% CI
Experimental
126.30
± 56.36
Active Control
127.25
± 63.93
4 Weeks Post-Vaccination B/Phuket
Group
Value
95% CI
Experimental
210.30
± 123.96
Active Control
229.57
± 135.63
16 Weeks Post-Vaccination A/Michigan
Group
Value
95% CI
Experimental
221.69
± 131.90
Active Control
203.03
± 119.41
16 Weeks Post-Vaccination A/Hong-Kong
Group
Value
95% CI
Experimental
283.67
± 126.72
Active Control
288.75
± 180.18
16 Weeks Post-Vaccination B/Brisbane
Group
Value
95% CI
Experimental
139.49
± 56.40
Active Control
144.47
± 76.77
16 Weeks Post-Vaccination B/Phuket
Group
Value
95% CI
Experimental
249.10
± 124.90
Active Control
271.70
± 176.16
Health Care UtilizationSecondary· Baseline to 6 months post-vaccination
Via medical records, we assessed health care usage potentially attributable to flu-like symptoms (e.g., GP visits, hospitalisation, antibiotic prescription) during the 6 months post-vaccination
GP Consultations
Group
Value
95% CI
Experimental
14
Active Control
13
Nurse Consultations
Group
Value
95% CI
Experimental
1
Active Control
1
Out of Hours/Telephone Conversations
Group
Value
95% CI
Experimental
7
Active Control
3
Emergency Department Consultations
Group
Value
95% CI
Experimental
1
Active Control
1
Antibiotic Prescriptions
Group
Value
95% CI
Experimental
6
Active Control
9
Additional Investigations (e.g., Xray)
Group
Value
95% CI
Experimental
4
Active Control
3
Sponsor's own description
This study is a 2-arm, parallel, randomised controlled feasibility trial of a brief video intervention designed to induce positive affect (mood) in older adults in primary care settings prior to the receipt of influenza vaccination. Participants will be randomised into two conditions: experimental and active control. In the experimental condition, participants will view the approximately 15 minute long intervention video immediately prior to vaccination. In the active control condition, participants will view a matched video that is designed to be mood neutral. Pre-and-post positive affect levels will be assessed by self-report questionnaires. Immune response to the intervention and vaccination responses will be assessed in saliva and serum samples respectively.
The objectives of the study are to assess the impact of the intervention on mood, immune function, and antibody response to influenza vaccination in older adults. This feasibility trial will also allow data collection on exploring recruitment, attrition, intervention engagement, and practicality of collecting clinical data available through electronic records to inform the design of a future definitive trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Nottingham
Last refreshed: 15 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03144518.