Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
NCT ID: NCT04052217
Last Updated: 2019-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2017-03-01
2019-08-01
Brief Summary
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Detailed Description
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The male participant will be asked to measure the length and girth of their erect penis using standardized instructions and flexible tape measure before the start of the experiment. This will partly determine the inner circumference of the ring provided. The male participant will be given instructions on how to use the penile rings and ensure that the female participant is blind to the size of the ring used.
There will be randomization (a) to the phase (the size of ring) and (b) the number of times of intercourse within a phase. The male partner will be blind to ratings made by the female partner. There is no carry over effect from one phase to another. The randomization of the phase means less guessing of the size of the ring, and less interaction with moderators (e.g. menstrual cycle, alcohol, holiday or life events randomly spread across phases). In a SCED, one then replicates in Case 2, Case 3 etc and a meta-analysis is conducted of all the single cases.
Randomisation will occur to either
1. Phase A "Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse)
2. Phase B - 1" ring randomised to either 3, 4, or 5 episodes of intercourse)
3. Phase C - 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse)
4. Phase D - 2" ring randomised to either 3, 4, or 5 episodes of intercourse) The male partner will be kept informed by text or email or phone (whichever is convenient) of when to change the size of ring and the number of times it should be used. The female partner will be asked to be blind to the size of ring used after each episode of intercourse. Blindness will be tested by asking if the female partner "saw" the size of the ring or whether she was able to guess when a change in the size of the ring occurred.
Measures:
The investigators will use a Visual Analogue Scale (0-100) for the female participant ratings of (a) sexual pleasure and (b) how emotionally connected she felt to her partner (c) any adverse experiences.
The female participant will be asked to rate the degree of change (positive or negative) that would be significant for them e.g. a drop of rating 65 to 45) The female participant will be asked to rate satisfaction and emotional closeness as soon as possible after intercourse. The investigators will ask all participants to enter the data directly onto web based capture of data. This will be anonymized so that they will be identified by a character.
The male participant will be asked to confirm the size of the ring used and any other comments.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Control Ring
"Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse (Phase A)
Penile Ring
Penile Ring at base of penis
1" RIng
Intercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B)
Penile Ring
Penile Ring at base of penis
1.5" Ring
Intercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C)
Penile Ring
Penile Ring at base of penis
2" Ring
Intercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D)
Penile Ring
Penile Ring at base of penis
Interventions
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Penile Ring
Penile Ring at base of penis
Eligibility Criteria
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Inclusion Criteria
2. Having regular intercourse (defined as on average twice a week).
Exclusion Criteria
2. Any current emotional disorder in either partner
3. Men with a micro-penis
18 Years
Yes
Sponsors
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King's College London
OTHER
Responsible Party
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Locations
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Centre for Anxiety Disorders and Trauma
London, , United Kingdom
Countries
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Other Identifiers
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HR-16/17-2018
Identifier Type: -
Identifier Source: org_study_id
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