Hip ArthropathyNCT06017128
Sexual Counseling's Impact on Hip Replacement Patients' Sexual Function and Quality of Life: a PLISSIT Model Study
A study testing sexual counseling based on the PLISSIT model in people with Hip Arthropathy and Sexual Function Disturbances, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the influence of sexual counseling using the PLISSIT model on various aspects of patients undergoing hip replacement. The PLISSIT model is employed to guide the counseling process. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hip Arthropathy, Sexual Function Disturbances, Quality of Life
- What is being tested?
- sexual counseling based on the PLISSIT model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18 to 70.
- Willingness to participate in the study.
- Scheduled to undergo hip replacement surgery.
- Being sexually active.
- Ability to engage in verbal communication and being literate.
Who cannot join
- Having a diagnosed history of a sexual disease in oneself or in one's partner (information about the participant's previous diagnoses will be obtained from the medical team involved in the study).
- Having diagnosed neurological and psychiatric disorders (information about the participant's previous diagnoses will be obtained from the medical team involved in the study).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Kadıköy
About this study
Official title: The Effect of Sexual Counseling Based on the PLISSIT Model on Sexual Function, Quality of Life, and Comfort in Patients Undergoing Hip Replacement
This study investigates the influence of sexual counseling using the PLISSIT model on various aspects of patients undergoing hip replacement. The PLISSIT model is employed to guide the counseling process. The research aims to assess how this counseling intervention affects sexual function, quality of life, and overall comfort for these patients. By addressing these factors, the study seeks to shed light on potential improvements in the well-being and experiences of individuals who have undergone hip replacement surgery.
Read the detailed description
To ensure the proper functioning of the body's systems and the fulfillment of an individual's needs, sufficient movement function is necessary. Decreased movement function, which is crucial for numerous physiological processes, negatively affects overall health status and vital functions. The hip joint is subjected to stress from activities such as walking, running, climbing stairs, lifting weights, and squatting throughout the day. Additionally, conditions like osteoarthritis and rheumatoid arthritis, which emerge with aging, lead to structural and functional abnormalities in the hip joint.
The severe pain and limited movement resulting from issues in the hip joint adversely impact daily life activities, diminishing quality of life. To alleviate pain, improve movement restrictions, and enhance quality of life, Total Hip Arthroplasty (THA) is one of the treatment options. Presently, due to advancements in surgical techniques and materials, THA has become a widely employed method. Literature also indicates increased comfort levels and improved quality of life for individuals after surgery.
One significant component of overall quality of life and general health is a healthy sexual function. Pain and movement limitations in the hip joint also negatively influence individuals' sexual lives. Stiffness, restricted movement, and severe pain in the hip joint lead individuals to be concerned about initiating sexual activity. Studies have shown that after Total Hip Arthroplasty, most patients experience an increase in sexual activity. With the elimination of pain and movement restrictions, individuals engage more comfortably in sexual activities.
However, despite the positive effects of total hip replacement, patients tend to avoid sexual activity due to factors like delayed wound healing, dislocation, joint noises, and uncertainty about resuming sexual relations. Individuals who cannot perform their sexual functions in a healthy manner are negatively affected both physically and psychologically. Moreover, the inability to experience a healthy sexual life, an integral part of marriage and intimate relationships, disrupts the connection between partners. Engaging in sexual activity at the wrong time or in inappropriate positions after surgery can increase the risk of dislocation and reoperation.
Due to all these reasons, the post-operative recovery process and patient comfort are adversely affected. Therefore, in the nursing care provided during the rehabilitation process after total hip replacement, individuals' sexual functions should not be overlooked. Collecting data on patients' sexual functions post-surgery and offering sexual counseling based on their needs are necessary. Detecting and resolving sexual issues are crucial for an effective and expedited post-operative rehabilitation and recovery process. This approach will contribute to the improvement of individuals' physical, social, and psychological health, leading to increased quality of life and comfort levels.
The use of models is highly important in evaluating and resolving individuals' sexual health. The utilization of the PLISSIT model is recommended in providing sexual counseling to healthcare professionals due to its ease of use and systematic approach. The PLISSIT model, developed by Annon in 1976 to guide the resolution of sexual issues, was revised by Taylor and Davis in 2006. The model consists of four stages: P-Permission, LI-Limited Information, SS-Specific Suggestions, and IT-Intensive Therapy.
P (Permission) - Permission: Boundaries for what individuals can and cannot discuss regarding sexuality should be established. In cases where these boundaries are not defined, individuals may not know what they should discuss. In this stage, nurses should allow patients to express their concerns about sexuality and sexual health and encourage them to do so.
LI (Limited Information) - Limited Information: The interventions in this stage aim to inform individuals about sexual matters. This stage involves reviewing the individual's knowledge about sexuality, discussing the effects of the disease and treatments on sexual function, providing information about these effects, and addressing concerns. Providing accurate information helps individuals cope more easily with their concerns about sexuality.
SS (Specific Suggestions) - Specific Suggestions: This stage includes providing individuals/spouses with specific information and recommendations for a more fulfilling sexual life. It is particularly effective for arousal and orgasm disorders and dyspareunia. The recommendations to be made depend on the sexual problem information obtained from the individual. Detailed recommendations such as different positions, interventions, and lubricants can be suggested to individuals with sexual problems.
IT (Intensive Therapy) - Intensive Therapy: This stage is the final stage of the PLISSIT model. If the first three stages of the model are unsuccessful, the intensive therapy stage is employed. The counselor needs to be an expert who has received additional training or should refer the individual to an appropriate unit to provide intensive therapy.
In the literature, it is generally observed that sexual counseling based on the PLISSIT model is provided to women experiencing sexual dysfunction due to reasons such as pregnancy, postpartum, hysterectomy, and mastectomy. Although studies have been conducted worldwide and in our country regarding sexual function after total hip replacement surgery, no study has been found that specifically provides sexual counseling based on the PLISSIT model.
- Being tested
- sexual counseling based on the PLISSIT model
- Keywords
- Hip Arthropaty, Sexual Function
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual counseling based on the PLISSIT modelOther
In the initial follow-up, the experimental group will receive information about total hip replacement surgery and its impact on sexual life based on the PLISSIT model. An educational booklet containing information about total hip replacement surgery, the rehabilitation process, and post-operative sexual life will also be prepared and distributed. In the second follow-up (5-7 days after surgery), the experimental group will be provided with information about home care before discharge and returning to sexual life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The experimental group will consist of individuals who will undergo total hip replacement surgery and receive sexual counseling along with an educational booklet. Receives: Other: sexual counseling based on the PLISSIT model |
| Control | No intervention | The control group will be comprised of individuals undergoing total hip replacement surgery without receiving sexual counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index
The highest score that can be obtained from the scale is 36 and the lowest score is 2. The cut-off score of the scale is 26.55. Those with a score of 26.55 or less are considered to have female sexual dysfunction. Female Sexual Function Index scores will increase after education according to PLISSIT Model.
Measured: 8 months
International Index of Erectile Function
The severity of erectile function in this area with a maximum score of 30; severe (6-10 points), moderate (11-16 points), mild (17-25 points) and no dysfunction (26 30 points). International Index of Erectile scores will increase after education according to PLISSIT Model.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Nov 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
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 Hip ArthropathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled, pre-test-post-test measurement experimental study was designed to determine the impact of sexual counseling based on the PLISSIT model on sexual function, quality of life, and comfort levels in individuals who have undergone total hip replacement surgery.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Eda Polat, Istanbul Medeniyet University
- Investigators
- Merve Tuncer, PhD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017128
- Sponsor's protocol ID
- IstanbulMU18
- Status last verified
- Nov 2024
- First submitted
- 22 Aug 2023
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers will make decisions based on the study outcomes.
Publications
Faghani S, Ghaffari F. Effects of Sexual Rehabilitation Using the PLISSIT Model on Quality of Sexual Life and Sexual Functioning in Post-Mastectomy Breast Cancer Survivors. Asian Pac J Cancer Prev. 2016 Nov 1;17(11):4845-4851. doi: 10.22034/APJCP.2016.17.11.4845.
PubMed 28030909Issa K, Pierce TP, Brothers A, Festa A, Scillia AJ, Mont MA. Sexual Activity After Total Hip Arthroplasty: A Systematic Review of the Outcomes. J Arthroplasty. 2017 Jan;32(1):336-340. doi: 10.1016/j.arth.2016.07.052. Epub 2016 Aug 11.
PubMed 27612606Ibrahimoglu O, Gezer N, Ogutlu O, Polat E. The Relationship Between Perioperative Care Quality and Postoperative Comfort Level in Patients With Hip Replacement Surgery. J Perianesth Nurs. 2023 Feb;38(1):69-75. doi: 10.1016/j.jopan.2022.05.068. Epub 2022 Aug 3.
PubMed 35931599Miettinen HJA, Makirinne-Kallio N, Kroger H, Miettinen SSA. Health-Related Quality of Life after Hip and Knee Arthroplasty Operations. Scand J Surg. 2021 Sep;110(3):427-433. doi: 10.1177/1457496920952232. Epub 2020 Aug 31.
PubMed 32862793Saray Kilic H, Tastan S. Development of post hip replacement comfort scale. Appl Nurs Res. 2017 Dec;38:169-174. doi: 10.1016/j.apnr.2017.10.004. Epub 2017 Oct 16.
PubMed 29241512Tuncer M, Oskay UY. Sexual Counseling with the PLISSIT Model: A Systematic Review. J Sex Marital Ther. 2022;48(3):309-318. doi: 10.1080/0092623X.2021.1998270. Epub 2021 Nov 17.
PubMed 34789082
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sexual Counseling Based on the PLISSIT Model on Sexual Function, Quality of Life, and Comfort in Patients Undergoing Hip Replacement
- ClinicalTrials.gov ID
- NCT06017128
- Acronym / sponsor ID
- IstanbulMU18
- Keywords
- Hip Arthropaty, Sexual Function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 Aug 2023 (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.
This study investigates the influence of sexual counseling using the PLISSIT model on various aspects of patients undergoing hip replacement. The PLISSIT model is employed to guide the counseling process. The research aims to assess how this counseling intervention affects sexual function, quality of life, and overall comfort for these patients. By addressing these factors, the study seeks to shed light on potential improvements in the well-being and experiences of individuals who have undergone hip replacement surgery.
Detailed description
To ensure the proper functioning of the body's systems and the fulfillment of an individual's needs, sufficient movement function is necessary. Decreased movement function, which is crucial for numerous physiological processes, negatively affects overall health status and vital functions. The hip joint is subjected to stress from activities such as walking, running, climbing stairs, lifting weights, and squatting throughout the day. Additionally, conditions like osteoarthritis and rheumatoid arthritis, which emerge with aging, lead to structural and functional abnormalities in the hip joint.
The severe pain and limited movement resulting from issues in the hip joint adversely impact daily life activities, diminishing quality of life. To alleviate pain, improve movement restrictions, and enhance quality of life, Total Hip Arthroplasty (THA) is one of the treatment options. Presently, due to advancements in surgical techniques and materials, THA has become a widely employed method. Literature also indicates increased comfort levels and improved quality of life for individuals after surgery.
One significant component of overall quality of life and general health is a healthy sexual function. Pain and movement limitations in the hip joint also negatively influence individuals' sexual lives. Stiffness, restricted movement, and severe pain in the hip joint lead individuals to be concerned about initiating sexual activity. Studies have shown that after Total Hip Arthroplasty, most patients experience an increase in sexual activity. With the elimination of pain and movement restrictions, individuals engage more comfortably in sexual activities.
However, despite the positive effects of total hip replacement, patients tend to avoid sexual activity due to factors like delayed wound healing, dislocation, joint noises, and uncertainty about resuming sexual relations. Individuals who cannot perform their sexual functions in a healthy manner are negatively affected both physically and psychologically. Moreover, the inability to experience a healthy sexual life, an integral part of marriage and intimate relationships, disrupts the connection between partners. Engaging in sexual activity at the wrong time or in inappropriate positions after surgery can increase the risk of dislocation and reoperation.
Due to all these reasons, the post-operative recovery process and patient comfort are adversely affected. Therefore, in the nursing care provided during the rehabilitation process after total hip replacement, individuals' sexual functions should not be overlooked. Collecting data on patients' sexual functions post-surgery and offering sexual counseling based on their needs are necessary. Detecting and resolving sexual issues are crucial for an effective and expedited post-operative rehabilitation and recovery process. This approach will contribute to the improvement of individuals' physical, social, and psychological health, leading to increased quality of life and comfort levels.
The use of models is highly important in evaluating and resolving individuals' sexual health. The utilization of the PLISSIT model is recommended in providing sexual counseling to healthcare professionals due to its ease of use and systematic approach. The PLISSIT model, developed by Annon in 1976 to guide the resolution of sexual issues, was revised by Taylor and Davis in 2006. The model consists of four stages: P-Permission, LI-Limited Information, SS-Specific Suggestions, and IT-Intensive Therapy.
P (Permission) - Permission: Boundaries for what individuals can and cannot discuss regarding sexuality should be established. In cases where these boundaries are not defined, individuals may not know what they should discuss. In this stage, nurses should allow patients to express their concerns about sexuality and sexual health and encourage them to do so.
LI (Limited Information) - Limited Information: The interventions in this stage aim to inform individuals about sexual matters. This stage involves reviewing the individual's knowledge about sexuality, discussing the effects of the disease and treatments on sexual function, providing information about these effects, and addressing concerns. Providing accurate information helps individuals cope more easily with their concerns about sexuality.
SS (Specific Suggestions) - Specific Suggestions: This stage includes providing individuals/spouses with specific information and recommendations for a more fulfilling sexual life. It is particularly effective for arousal and orgasm disorders and dyspareunia. The recommendations to be made depend on the sexual problem information obtained from the individual. Detailed recommendations such as different positions, interventions, and lubricants can be suggested to individuals with sexual problems.
IT (Intensive Therapy) - Intensive Therapy: This stage is the final stage of the PLISSIT model. If the first three stages of the model are unsuccessful, the intensive therapy stage is employed. The counselor needs to be an expert who has received additional training or should refer the individual to an appropriate unit to provide intensive therapy.
In the literature, it is generally observed that sexual counseling based on the PLISSIT model is provided to women experiencing sexual dysfunction due to reasons such as pregnancy, postpartum, hysterectomy, and mastectomy. Although studies have been conducted worldwide and in our country regarding sexual function after total hip replacement surgery, no study has been found that specifically provides sexual counseling based on the PLISSIT model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized controlled, pre-test-post-test measurement experimental study was designed to determine the impact of sexual counseling based on the PLISSIT model on sexual function, quality of life, and comfort levels in individuals who have undergone total hip replacement surgery.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: sexual counseling based on the PLISSIT modelThe experimental group will consist of individuals who will undergo total hip replacement surgery and receive sexual counseling along with an educational booklet. |
| Control | No intervention | –The control group will be comprised of individuals undergoing total hip replacement surgery without receiving sexual counseling. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 18 to 70.
- Willingness to participate in the study.
- Scheduled to undergo hip replacement surgery.
- Being sexually active.
- Ability to engage in verbal communication and being literate.
Key exclusion criteria (2 listed)
- Having a diagnosed history of a sexual disease in oneself or in one's partner (information about the participant's previous diagnoses will be obtained from the medical team involved in the study).
- Having diagnosed neurological and psychiatric disorders (information about the participant's previous diagnoses will be obtained from the medical team involved in the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sexual counseling based on the PLISSIT modelIn the initial follow-up, the experimental group will receive information about total hip replacement surgery and its impact on sexual life based on the PLISSIT model. An educational booklet containing information about total hip replacement surgery, the rehabilitation process, and post-operative sexual life will also be prepared and distributed. In the second follow-up (5-7 days after surgery), the experimental group will be provided with information about home care before discharge and returning to sexual life. | Other | Intervention |
Primary outcome
Female Sexual Function Index
Time frame: 8 months
The highest score that can be obtained from the scale is 36 and the lowest score is 2. The cut-off score of the scale is 26.55. Those with a score of 26.55 or less are considered to have female sexual dysfunction. Female Sexual Function Index scores will increase after education according to PLISSIT Model.
International Index of Erectile Function
Time frame: 8 months
The severity of erectile function in this area with a maximum score of 30; severe (6-10 points), moderate (11-16 points), mild (17-25 points) and no dysfunction (26 30 points). International Index of Erectile scores will increase after education according to PLISSIT Model.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 28030909Faghani S, Ghaffari F. Effects of Sexual Rehabilitation Using the PLISSIT Model on Quality of Sexual Life and Sexual Functioning in Post-Mastectomy Breast Cancer Survivors. Asian Pac J Cancer Prev. 2016 Nov 1;17(11):4845-4851. doi: 10.22034/APJCP.2016.17.11.4845.
- Background: PubMed 27612606Issa K, Pierce TP, Brothers A, Festa A, Scillia AJ, Mont MA. Sexual Activity After Total Hip Arthroplasty: A Systematic Review of the Outcomes. J Arthroplasty. 2017 Jan;32(1):336-340. doi: 10.1016/j.arth.2016.07.052. Epub 2016 Aug 11.
- Background: PubMed 35931599Ibrahimoglu O, Gezer N, Ogutlu O, Polat E. The Relationship Between Perioperative Care Quality and Postoperative Comfort Level in Patients With Hip Replacement Surgery. J Perianesth Nurs. 2023 Feb;38(1):69-75. doi: 10.1016/j.jopan.2022.05.068. Epub 2022 Aug 3.
- Background: PubMed 32862793Miettinen HJA, Makirinne-Kallio N, Kroger H, Miettinen SSA. Health-Related Quality of Life after Hip and Knee Arthroplasty Operations. Scand J Surg. 2021 Sep;110(3):427-433. doi: 10.1177/1457496920952232. Epub 2020 Aug 31.
- Background: PubMed 29241512Saray Kilic H, Tastan S. Development of post hip replacement comfort scale. Appl Nurs Res. 2017 Dec;38:169-174. doi: 10.1016/j.apnr.2017.10.004. Epub 2017 Oct 16.
- Background: PubMed 34789082Tuncer M, Oskay UY. Sexual Counseling with the PLISSIT Model: A Systematic Review. J Sex Marital Ther. 2022;48(3):309-318. doi: 10.1080/0092623X.2021.1998270. Epub 2021 Nov 17.
- Individual participant dataSharing planned: No. The researchers will make decisions based on the study outcomes.
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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.
Merve Tuncer, PhD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexual counseling based on the PLISSIT model in people with Hip Arthropathy and Sexual Function Disturbances, run by Istanbul Medeniyet 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Female Sexual Function Index (time frame: 8 months). The study lists 2 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 NCT06017128, 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 19 Nov 2024.