Obesity, MorbidNCT04364841
Body Image and Sexuality After Bariatric Surgery
An observational study of Obesity, Morbid and Sexual Dysfunction, Physiological, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Sexual Dysfunction, Physiological
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Dec 2018
- How long will I take part?
- 19 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Accepted to join the study,
- Did not have such psychiatric disorders as anxiety, depression and personality disorders
- Were aged between 18 and 65.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bariatric Surgery on Body Image Level and Sexual Life of Individuals
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.
Read the detailed description
Obese individuals who want to learn healthy life behaviors and wish to acquire and to realize behavioral changes that will help them cope with health problems are in need of training and counseling. In this process, nurses -being in close and continuous contact with individuals- play counselor role as a part of their educator roles. It is stated that nurses need to understand, empathize with and support individuals who suffer from different problems while they play this role. In presence of obesity, which is a psychophysiological condition; nurses should also consider the fact that obese individuals who face bitter criticisms and social exclusion may show low self-esteem and impaired body image due to excessive weight and therefore they should give these individuals opportunities to express their feelings as to how they perceive themselves. The studies in literature that investigated the correlation between body mass index (BMI) and self-esteem and body perception report that obese individuals demonstrate relatively lower self-esteem and body perception as compared to the normal individuals. Psychological and hormonal disorders, impaired body image and chronic diseases that develop with obesity influence sexual life negatively, too. Therefore; 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.
- Conditions
- Obesity, Morbid, Sexual Dysfunction, Physiological
- Keywords
- bariatric surgery, body image, sexuality, obesity
- Medical subject headings
- Obesity, Morbid, Sexual Dysfunction, Physiological, Sexuality, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 day
Secondary outcomes (2)
Obese individuals' Body Perception as assessed by "Body Perception Scale" at the post-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 post-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.
Measured: 1 day
Obese individuals' sexual functions respective of sexual orientation as assessed by "Arizona Sexual Experiences Scale " at the post-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 post-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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Jun 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
- Target duration
- 19 Months
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EBRU YILDIZ, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364841
- Sponsor's protocol ID
- Sexuality and obesity
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaya H. Patient education in health services and responsibilities of nurse: review. Turkiye Klinikleri Journal of Nursing Sciences. 2009; 1: 19-23.
Tedik SE. Healthy life and role of nursing in thecontrol of body weight. TurkishJ ournal of Diabetes and Obesity. 2017; 2: 54-62.
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.
PubMed 19968771Hamurcu 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.
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.
PubMed 27567073Hall 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bariatric Surgery on Body Image Level and Sexual Life of Individuals
- ClinicalTrials.gov ID
- NCT04364841
- Acronym / sponsor ID
- Sexuality and obesity
- Conditions
- Obesity, Morbid, Sexual Dysfunction, Physiological
- Keywords
- bariatric surgery, body image, sexuality, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obese individuals who want to learn healthy life behaviors and wish to acquire and to realize behavioral changes that will help them cope with health problems are in need of training and counseling. In this process, nurses -being in close and continuous contact with individuals- play counselor role as a part of their educator roles. It is stated that nurses need to understand, empathize with and support individuals who suffer from different problems while they play this role. In presence of obesity, which is a psychophysiological condition; nurses should also consider the fact that obese individuals who face bitter criticisms and social exclusion may show low self-esteem and impaired body image due to excessive weight and therefore they should give these individuals opportunities to express their feelings as to how they perceive themselves. The studies in literature that investigated the correlation between body mass index (BMI) and self-esteem and body perception report that obese individuals demonstrate relatively lower self-esteem and body perception as compared to the normal individuals. Psychological and hormonal disorders, impaired body image and chronic diseases that develop with obesity influence sexual life negatively, too. Therefore; 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 19 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Accepted to join the study,
- Did not have such psychiatric disorders as anxiety, depression and personality disorders
- Were aged between 18 and 65.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obese individuals' Descriptive Characteristics and Findings Related to the Disease as assessed by "Information Request Form".
Time frame: 1 day
At the first stage of the research, by the obese individuals "Information Request Form" is filled in to specify socio-demographic characteristics.
Obese individuals' Body Perception as assessed by "Body Perception Scale" at the pre-operation period
Time frame: 1 day
"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.
Obese individuals' sexual functions respective of sexual orientation as assessed by "Arizona Sexual Experiences Scale " at the pre-operation period
Time frame: 1 day
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.
2 secondary outcomes
Obese individuals' Body Perception as assessed by "Body Perception Scale" at the post-operation period
Time frame: 1 day
Obese individuals' sexual functions respective of sexual orientation as assessed by "Arizona Sexual Experiences Scale " at the post-operation period
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- BackgroundKaya H. Patient education in health services and responsibilities of nurse: review. Turkiye Klinikleri Journal of Nursing Sciences. 2009; 1: 19-23.
- BackgroundTedik SE. Healthy life and role of nursing in thecontrol of body weight. TurkishJ ournal of Diabetes and Obesity. 2017; 2: 54-62.
- Background: PubMed 19968771Pujols 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.
- BackgroundHamurcu 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: PubMed 27567073Wallwiener 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.
- BackgroundHall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Sexual Dysfunction, Physiological, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obese individuals' Descriptive Characteristics and Findings Related to the Disease as assessed by "Information Request Form". (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364841, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.