NCT04364841

Brief Summary

Sexual desire may decrease among obese individuals who feel worthless and therefore there may be behaviors that avoid sexuality. Sexuality, one of the activities of daily life, is an issue that is affected by cultural norms and rules and individuals have difficulties expressing their sexual problems comfortably. In a systematic review which is about the effect of bariatric surgery on sexuality; it was emphasized that bariatric surgery, the most widely used treatment in obesity, has positive effects upon reproductive hormones and sexual functions thanks to weight loss. In light of these information above-mentioned; the study was done to examine the correlation between body perception and sexual life before and after bariatric surgery among obese individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 23, 2020

Last Update Submit

April 28, 2020

Conditions

Keywords

bariatric surgerybody imagesexualityobesity

Outcome Measures

Primary Outcomes (3)

  • Obese individuals' Descriptive Characteristics and Findings Related to the Disease as assessed by "Information Request Form".

    At the first stage of the research, by the obese individuals "Information Request Form" is filled in to specify socio-demographic characteristics.

    1 day

  • Obese individuals' Body Perception as assessed by "Body Perception Scale" at the pre-operation period

    "Body Perception Scale" filled in to determine how satisfied they were the various parts of their bodies and various body functions at the pre-operation period by the obese individuals. The scale includes 40 items and each item refers to an organ or a limb (arm, leg, face, etc.) or a function (sexual activity level). Each item score ranges from 1 to 5 by marking "I do not like at all", "I do not like", "I am uncertain", "I like", "I like a lot". Total score ranges from 40 to 200. High scores indicate high level of satisfaction. Cutoff score of the scale was 135 and scores lower than 135 (≥135) indicate lower body perception.

    1 day

  • Obese individuals' sexual functions respective of sexual orientation as assessed by "Arizona Sexual Experiences Scale " at the pre-operation period

    The "Arizona Sexual Experiences Scale" was filled in to measure sexual functions related to sexual orientation and the relationship with partners at the pre-operation period by the obese individuals. Scores for each question range from 1 to 6 and total score ranges from 5 to 30. Lower scores indicate strong, easy and satisfactory sexual response while higher scores indicate presence of sexual dysfunctions. According to Soykan, a score ≥11 is a cutoff score for sexual dysfunction.

    1 day

Secondary Outcomes (2)

  • Obese individuals' Body Perception as assessed by "Body Perception Scale" at the post-operation period

    1 day

  • Obese individuals' sexual functions respective of sexual orientation as assessed by "Arizona Sexual Experiences Scale " at the post-operation period

    1 day

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population of the study was consisted of 33 patients who received obesity diagnosis at General Surgery Unit, Mersin University Hospital and underwent bariatric surgery between 1.6.2017 and 1.12.2018. It was identified that the number of the patients who had bariatric surgery at the hospital between 30.11.2016 and 30.5.2017 was 33. During the sampling phase, at least 27 of the 33 patients who volunteered to join the study and met inclusion and exclusion criteria were targeted between 01.06.2017 and 01.12.2018 when Data Collection Forms were distributed according to the statistical calculations in which 20% loss of the population was predicted. However, the whole population was achieved.

You may qualify if:

  • Accepted to join the study,
  • Did not have such psychiatric disorders as anxiety, depression and personality disorders
  • Were aged between 18 and 65.

You may not qualify if:

  • Do not accepting to join the study,
  • Have such psychiatric disorders as anxiety, depression and personality disorders
  • Older from 65, under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Nursing

Mersin, Turkey (Türkiye)

Location

Related Publications (6)

  • Kaya H. Patient education in health services and responsibilities of nurse: review. Turkiye Klinikleri Journal of Nursing Sciences. 2009; 1: 19-23.

    BACKGROUND
  • Tedik SE. Healthy life and role of nursing in thecontrol of body weight. TurkishJ ournal of Diabetes and Obesity. 2017; 2: 54-62.

    BACKGROUND
  • Pujols Y, Seal BN, Meston CM. The association between sexual satisfaction and body image in women. J Sex Med. 2010 Feb;7(2 Pt 2):905-16. doi: 10.1111/j.1743-6109.2009.01604.x. Epub 2009 Nov 24.

    PMID: 19968771BACKGROUND
  • Hamurcu P, Öner C, Telatar B, Yeşildağ Ş. The impact of obesity on self esteem and body image. Turkish Journal of Family Practice. 2015; 19: 122-128.

    BACKGROUND
  • Wallwiener S, Strohmaier J, Wallwiener LM, Schonfisch B, Zipfel S, Brucker SY, Rietschel M, Wallwiener CW. Sexual Function Is Correlated With Body Image and Partnership Quality in Female University Students. J Sex Med. 2016 Oct;13(10):1530-8. doi: 10.1016/j.jsxm.2016.07.020. Epub 2016 Aug 23.

    PMID: 27567073BACKGROUND
  • Hall AM. Sexuality. In (Chapter 28) : Potter, P. A, Perry, A. G. E., Hall, A. E. & Stockert, P. A. (ed.), (2009). Fundamentals of nursing. Elsevier Mosby. pp: 426-442.

    BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidSexual Dysfunction, PhysiologicalSexualityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital DiseasesSexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
19 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 28, 2020

Study Start

June 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations