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Postpartum Sexual DysfunctionNCT06632366

The Effect of Self-Compassion Training on Sexual Life Quality and Marital Adjustment in Women With Sexual Dysfunction

A study testing Sexual Dysfunction in the Postpartum Period in people with Postpartum Sexual Dysfunction, run by Inonu University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Sexual function in the postpartum period, the gateway to newness and change, can be affected by problems such as caring for a new baby, breastfeeding, fatigue, anxiety about pain during sexual intercourse, postpartum depression, pelvic floor dysfunction, urinary symptoms and body image. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Postpartum Sexual Dysfunction
What is being tested?
Sexual Dysfunction in the Postpartum Period
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Feb 2024to 30 Jun 2025
Phase
Interventional
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Erbal communicator and no literacy disability,
  • Living with his wife,
  • Beginning postpartum sexual intercourse, menstrual cycle has not started
  • Between 2-6 months postpartum,
  • Having a healthy baby
  • Menstrual cycle has not started
  • Women diagnosed with sexual dysfunction (total score ≥19) according to the Arizona
  • Sexual Experiences Scale will be included in the study.

Who cannot join

  • Having undergone gynecological surgery during the study,
  • Have been or are currently diagnosed with a psychiatric illness,
  • Having attended any awareness-based training at least 6 months ago

Trial locations and contacts

1 site in 1 country.

Fadime Biçer Şahin, MSc contact

05522980842

fadimebicer42@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Gaziantep Provincial Directorate of Health

    Gaziantep

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect Of Awareness-Based Self-Compassage Educatıon Gıven To Women Experıenced Sexual Dysfunctıon In The Postpartum Perıod On The Qualıty Of Sexual Lıfe And Partnershıp

Sexual function in the postpartum period, the gateway to newness and change, can be affected by problems such as caring for a new baby, breastfeeding, fatigue, anxiety about pain during sexual intercourse, postpartum depression, pelvic floor dysfunction, urinary symptoms and body image. Changes in sexual function are common in the postpartum period. Pregnancy and childbirth is a period in a woman's life that causes hormonal and physical changes and has an impact on the parents' quality of life.

Postpartum sexual function is an important issue for couples, as the first sexual intercourse after childbirth is an important step for couples to establish intimate relationships. Many factors affect postpartum sexual dysfunction, including number of births, breastfeeding, mode of delivery, episiotomy, physical and psychological dysfunction, including fatigue and postpartum depression. Without adequate information and counseling on sexual life by health professionals in the postpartum period, most women may remain silent about their sexual concerns and anxieties, preferring instead to share their problems with friends. More holistic and multidisciplinary approaches are needed to treat female sexual dysfunctions. The use of mindfulness-based therapies has recently become widespread in the treatment of women diagnosed with sexual dysfunction.Thanks to mindfulness practices, it has been observed that women perceive stimuli better and are able to notice clues that they did not notice before. The Compassion Focused Therapy program is one of these practices. It is known to integrate well with existing approaches to therapy and offers some useful ways of reducing sexual problems to provide a coherent rationale for treatment strategies.

Read the detailed description

The postpartum period is a 6-12-week period that starts with the delivery of the placenta and continues with the disappearance of the physiologic and anatomic changes that occurred during pregnancy . Spousal and family support is very important for a healthy and harmonious passage of this period. With the realization of delivery, the mode of delivery, body image changes, hormonal changes, lactation and breast problems, fatigue, vaginal bleeding, problems related to the baby, sexual reluctance and the relationship between spouses affect the sexual life of women. Although the time to start postpartum sexual intercourse varies from person to person and culture to culture, this period is traditionally 6 weeks. As a result of the studies, it is reported that the time to start postpartum sexual intercourse is between 5-8 weeks. Couples are concerned about starting sexual intercourse when there is bleeding, laceration or episiotomy in the woman in the postpartum period. Physiologic changes that occur during pregnancy and delivery affect sexual intercourse in the postpartum period, and perineal pain and dyspareunia due to episiotomy and laceration are observed in women. However, according to studies, sexual function problems encountered by women in this period include dyspareunia, pelvic floor dysfunction, vaginal dryness, sexual desire / intercourse. satisfaction as a decrease in sexual satisfaction. In a study conducted by Lagaert et al. with 109 women in the postpartum period; women who had spontaneous vaginal delivery and women who had interventional delivery were compared and women who had interventional delivery stated that they experienced more painful sexual intercourse . In the postpartum period, reasons such as episiotomy, perineal pain, vaginal bleeding and discharge, fatigue, pelvic floor dysfunction, feeling less attractive due to physical changes lead to a decrease in sexual desire and consequently to withdrawal from sexuality.

During the first year after birth, new parents face many personal and interpersonal changes, including changes in their sexual relationships. In particular, it has been found that most new parents experience sexual concerns specific to the postpartum period, wondering when to restart sexual intercourse after birth, pain during sexual intercourse, and the impact of body image concerns on sexual activity. Lorenz et al. found that couples generally experienced a decrease in the frequency of sexual activity in the postpartum phase . In a study conducted with 1507 women in the postpartum period, 89% of women were reported to have sexual health problems. In the postpartum 3rd month, the most common complaints were loss of sexual desire, pain during sexual intercourse, and vaginal dryness. Although traditional and complementary treatment practices are utilized in the treatment of sexual dysfunctions, the effectiveness of very few of them has been shown in studies with high level of evidence. Traditional and Complementary Medicine practices used in sexual dysfunctions include natural products (plants, vitamins, minerals and probiotics etc.), mind and body practices such as yoga, mindfulness-based intervention, acupuncture and other methods. The use of mindfulness-based therapies has recently become widespread in the treatment methods of women diagnosed with sexual dysfunction. With these therapies, it has been observed that there is a significant improvement in general sexual function level, arousal and sexual problems. Through mindfulness practices, it has been observed that women perceive stimuli better and are able to recognize clues that they did not notice before. Compassionate mindfulness program is one of these practices. CFT (Compassion Focused Therapy) is known to integrate well with existing approaches to psychosexual therapy and offers some useful ways to reduce sexual problems to provide a coherent rationale for treatment strategies .Self-compassion proceeds in parallel with the individual's self-knowledge, acceptance, positive perspective towards life, social activities, consciousness, character structure open to development and subjectivity. There is an inverse relationship with anxiety disorder, mental depression and the negativities provided by negative situations.

In order to develop compassionate involvement in therapy, the therapist's non-judgmental, warm and encouraging stance when talking about sexual intercourse, as well as detailed information about sexual difficulties, can be a starting point for the client to cope with the difficulties they experience. The therapist can then use a normalizing and non-shaming CFT (Compassion Focused Therapy) formulation to help the client turn towards the difficulties they are experiencing and look at them with understanding. In this sense, the place of midwives who are in constant one-to-one communication with women in the protection and development of sexual health is very important. Determining the sexual needs of women in any period of women's life, eliminating sexual problems, explaining behaviors and attitudes related to sexual life, providing education and guidance are among the roles of midwifery. Midwives have the responsibilities of taking anamnesis, identifying sexual problems and providing education and counseling for these problems in order to maintain and increase the sexual health of pregnant women during pregnancy. It is important for midwives to communicate as a very good listener, to take into account the concerns of the woman, to ask effective questions, to speak by reassuring and stating that privacy will be ensured, to identify the sexual problems of the woman and to provide effective counseling.

Being tested
Sexual Dysfunction in the Postpartum Period
Keywords
postpartum, midwifery, sexuality
Medical subject headings
Sexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sexual Dysfunction in the Postpartum PeriodOther

    The experimental group will receive mindfulness-based self-compassion training. The control group will not receive any intervention.

Study groups in NCT06632366
Study groupRoleWhat they receive
Sexual Dysfunction in the Postpartum PeriodExperimentalIn the research, Awareness-Based Self-Compassion Training sessions will be held with the women in the experimental group twice a week for 3 weeks, six times in total.Women in the postpartum period included in the control group will be interviewed twice in total. In the first interview, the "Personal Information Form", "Sexual Life Quality Scale-Female" and "Male Compatibility Scale" will be applied and pre-test data will be obtained. Eight weeks after the pre-test data is obtained, post-test data will be obtained by applying the "Arizona Sexual Experiences Scale-Female", "Sexual Quality of Life Scale-Female" and "Dutch Compatibility Scale".
Receives: Other: Sexual Dysfunction in the Postpartum Period
controlNo interventionWomen in the postpartum period included in the control group will be interviewed twice in total. In the first interview, the "Personal Information Form", "Sexual Life Quality Scale-Female" and "Male Compatibility Scale" will be applied and pre-test data will be obtained. Eight weeks after the pre-test data is obtained, post-test data will be obtained by applying the "Arizona Sexual Experiences Scale-Female", "Sexual Quality of Life Scale-Female" and "Dutch Compatibility Scale".

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arizona Sexual Experiences Scale- Female (ASES-F)

    The female form includes questions investigating sexual drive, psychological arousal, physiological arousal (vaginal lubrication), the capacity to reach orgasm and the feeling of satisfaction after orgasm. Each question in the scale is scored from 1 to 6, and the minimum score that can be obtained from the total score is 5 and the maximum is 30. A total score of 19 and above from the scale, a score of 5 or 6 for any item or a score of 4 for three or more items indicates the presence of sexual dysfunction. While low scores represent that the sexual response is effective, comfortable and satisfying, high scores indicate the presence of sexual dysfunction. The total internal consistency coefficient of the scale is 0.89 and the Cronbach alpha reliability coefficient is 0.90.

    Measured: ten weeks

Secondary outcomes (1)
  1. Sexual Quality of Life Scale- Female (SQOL-F)

    The reliability level of the scale was determined to be high and the reliability coefficient of the scale and the Cronbach alpha value are equal to each other and are 0.83. The scale, which consists of a total of 18 questions, requires answers to problems related to sexual life, including the last 4 weeks. The scale is Likert-type and has a six-point response option. The scoring system of the scale is between 0 and 5 or 1 and 6. The minimum and maximum score that can be obtained from the scale is 18-108. In addition, when the scale is scored between 0 and 5, the score range is 0-90. High scores obtained from the scale indicate that the quality of sexual life is good. The reliability of the scale, which has a reliability coefficient and Cronbach alpha value of 0.83, is high.

    Measured: ten weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start5 Feb 2024
  3. Primary completion1 Feb 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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 research was designed as a randomized controlled experimental type.
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632366
Sponsor's protocol ID
17
Other IDs
Hacer ÜNVER KOCA
Status last verified
Oct 2024
First submitted
26 Apr 2024
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bolsoy N, Sen S, Sezer G, Cakil M. The effect of training on women with postpartum sexual dysfunction: A randomized controlled trial. Niger J Clin Pract. 2023 Jul;26(7):949-956. doi: 10.4103/njcp.njcp_656_22.

    PubMed 37635579
  • De Souza A, Dwyer PL, Charity M, Thomas E, Ferreira CH, Schierlitz L. The effects of mode delivery on postpartum sexual function: a prospective study. BJOG. 2015 Sep;122(10):1410-8. doi: 10.1111/1471-0528.13331. Epub 2015 Mar 6.

    PubMed 25752211
  • Bhat GS, Shastry A. Sexually Induced Orgasm to Improve Postpartum Pelvic Floor Muscle Strength and Sexual Function in Primiparous Women After Vaginal Delivery: A Prospective Randomized Two-Arm Study. J Sex Med. 2022 Nov;19(11):1634-1643. doi: 10.1016/j.jsxm.2022.08.189. Epub 2022 Sep 25.

    PubMed 36167664
  • Kolberg Tennfjord M, Hilde G, Staer-Jensen J, Siafarikas F, Engh ME, Bo K. Effect of postpartum pelvic floor muscle training on vaginal symptoms and sexual dysfunction-secondary analysis of a randomised trial. BJOG. 2016 Mar;123(4):634-42. doi: 10.1111/1471-0528.13823. Epub 2015 Dec 22.

    PubMed 26691895

Questions about this trial

What is this clinical trial studying?

A study testing Sexual Dysfunction in the Postpartum Period in people with Postpartum Sexual Dysfunction, run by Inonu 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 8 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: status not confirmed, as of the sponsor's last update on 9 Oct 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fadime Biçer Şahin, MSc (05522980842, fadimebicer42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arizona Sexual Experiences Scale- Female (ASES-F) (time frame: ten weeks). 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 NCT06632366, which also lists 4 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 9 Oct 2024.

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