Ignite Creation Date:
2024-05-06 @ 1:32 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04052217
Status:
COMPLETED
Last Update Posted:
2019-08-09
First Post:
2019-08-07
Brief Title:
Does Size Matter A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Does Size Matter A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our hypothesis is that reducing the length of the penis does not lead to loss of sexual satisfaction or emotional closeness in the female partner This will be investigated by a single case experimental design in 12 couples
Detailed Description:
The investigators will conduct a single case experimental design SCED in which a woman acts as her own control with a reversal design between randomly allocated phases These include a control phase A and phases with various sizes of penile rings B C and D
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 eg 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 05cm 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 - 15 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 eg 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
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 eg 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 05cm 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 - 15 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None