Women's HealthNCT03839147
The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography
A study testing Education and counseling in people with Women's Health, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
This study investigates the effect of education and counseling on anxiety and pain in women undergoing hysterosalpingography as part of the infertility process. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women's Health
- What is being tested?
- Education and counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Jan 2017
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- being diagnosed with infertility
- negative the result of the B-HCG testing
- being able to understand, read and write in Turkish
Who cannot join
- not wanting to be included in the study
- not accepting education/counseling
- not knowing Turkish
- having additional diseases related to pelvic pain
About this study
This study investigates the effect of education and counseling on anxiety and pain in women undergoing hysterosalpingography as part of the infertility process.
Read the detailed description
Fertility and having a child is a significant experience for most individuals; however, many struggle to achieve pregnancy. Infertility is defined as the inability of a couple to conceive after 12 months of regular unprotected sexual intercourse or to carry a pregnancy to term. It is estimated that 10-15 % of the couples globally experience infertility. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples, hysterosalpingography (HSG) is a simple, safe, and minimally invasive radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG plays an important diagnostic role in finding the cause of infertility and in deciding the line of management. The aim of this study was to investigate the effect of education and counseling on anxiety and pain before the treatment of women who will have HSG procedure with the diagnosis of infertility.
This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. Volunteer women undergoing HSG as part of infertility evaluation have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores was used for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the data obtained in the study.
- Conditions
- Women's Health
- Being tested
- Education and counseling
- Keywords
- hysterosalpingography, anxiety, pain, education, counseling
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and counselingBehavioural
After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher was repeated briefly on the morning of the HSG procedure and any questions of the patients were answered.
| Study group | Role | What they receive |
|---|---|---|
| Education and Counseling | Experimental | After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale were applied to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. This education consisted of the definition and the purpose of hysterosalpingography, when and how it was applied, in what cases it was applied, whether it was a painful procedure, possible side effects and additional benefits of infertility treatment Receives: Behavioral: Education and counseling |
| Control group | No intervention | Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed. Both groups were re-evaluated using the same scales after the hysterosalpingography. Within 5 minutes of completing the hysterosalpingography procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State Anxiety Scale
After completing the HSG procedure, participants filled out the Spielberger State Anxiety Scale.
The Spielberger state anxiety scale was developed in 1964 by Spielberger. There are 20 statements in the scale that individuals can use to express their feelings. The State Scale measures the level of anxiety related to the situation and has been scored by four options for each expression. These are: "None" (1), "Slightly" (2), "Many" (3), "Completely" (4). The statements in this section are divided directly and reversed. Reversed statements are 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20.
The total score of the expressions which are reversed from the total score of the direct expressions and adding the number 50 which is the constant value of the state anxiety scale. Spielberger and his colleagues stated that 0-19 points obtained from the scale meant "no anxiety", 20-39 points meant "light", 40-59 points meant "medium", 60-79 points meant "heavy anxiety".
Measured: 30 minutes
Visual Analog Scale for pain intensity
After completing the HSG procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). Patients indicated the maximum pain intensity experienced during the HSG by making a vertical line on the VAS.
A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 May 2016
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Women's HealthStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gulten Guvenc, Principal investigator, University of Health Sciences, Gulhane Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839147
- Sponsor's protocol ID
- 50687469
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aba YA, Avci D, Guzel Y, Ozcelik SK, Gurtekin B. Effect of music therapy on the anxiety levels and pregnancy rate of women undergoing in vitro fertilization-embryo transfer: A randomized controlled trial. Appl Nurs Res. 2017 Aug;36:19-24. doi: 10.1016/j.apnr.2017.05.005. Epub 2017 May 22.
PubMed 28720234Onwuchekwa CR, Oriji VK. Hysterosalpingographic (HSG) Pattern of Infertility in Women of Reproductive Age. J Hum Reprod Sci. 2017 Jul-Sep;10(3):178-184. doi: 10.4103/jhrs.JHRS_121_16.
PubMed 29142446Stevenson EL, Hershberger PE, Bergh PA. Evidence-Based Care for Couples With Infertility. J Obstet Gynecol Neonatal Nurs. 2016 Jan-Feb;45(1):100-10; quiz e1-2. doi: 10.1016/j.jogn.2015.10.006. Epub 2015 Dec 1.
PubMed 26815804
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography
- ClinicalTrials.gov ID
- NCT03839147
- Acronym / sponsor ID
- 50687469
- Conditions
- Women's Health
- Keywords
- hysterosalpingography, anxiety, pain, education, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 15 Feb 2019 (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 effect of education and counseling on anxiety and pain in women undergoing hysterosalpingography as part of the infertility process.
Detailed description
Fertility and having a child is a significant experience for most individuals; however, many struggle to achieve pregnancy. Infertility is defined as the inability of a couple to conceive after 12 months of regular unprotected sexual intercourse or to carry a pregnancy to term. It is estimated that 10-15 % of the couples globally experience infertility. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples, hysterosalpingography (HSG) is a simple, safe, and minimally invasive radiologic procedure to visualize uterine cavity and tubes after contrast enhancement. HSG plays an important diagnostic role in finding the cause of infertility and in deciding the line of management. The aim of this study was to investigate the effect of education and counseling on anxiety and pain before the treatment of women who will have HSG procedure with the diagnosis of infertility.
This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. Volunteer women undergoing HSG as part of infertility evaluation have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores was used for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 22.0 package program was used to evaluate the data obtained in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized controlled study was conducted at Gulhane Training and Research Hospital, Obstetrics and Gynecology clinic between May 2016 and January 2017. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
| Arm | Type | Receives |
|---|---|---|
| Education and Counseling | Experimental | Behavioral: Education and counselingAfter obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and visual analogue scale scoring scale were applied to both groups by face to face interview during the day giving appointment for hysterosalpingography. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. This education consisted of the definition and the purpose of hysterosalpingography, when and how it was applied, in what cases it was applied, whether it was a painful procedure, possible side effects and additional benefits of infertility treatment |
| Control group | No intervention | –Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed. Both groups were re-evaluated using the same scales after the hysterosalpingography. Within 5 minutes of completing the hysterosalpingography procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the visual analogue scale . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being diagnosed with infertility
- negative the result of the B-HCG testing
- being able to understand, read and write in Turkish
Key exclusion criteria (4 listed)
- not wanting to be included in the study
- not accepting education/counseling
- not knowing Turkish
- having additional diseases related to pelvic pain
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 |
|---|---|---|
| Education and counselingAfter obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher was repeated briefly on the morning of the HSG procedure and any questions of the patients were answered. | Behavioural | Education and Counseling |
Primary outcome
Spielberger State Anxiety Scale
Time frame: 30 minutes
After completing the HSG procedure, participants filled out the Spielberger State Anxiety Scale. The Spielberger state anxiety scale was developed in 1964 by Spielberger. There are 20 statements in the scale that individuals can use to express their feelings. The State Scale measures the level of anxiety related to the situation and has been scored by four options for each expression. These are: "None" (1), "Slightly" (2), "Many" (3), "Completely" (4). The statements in this section are divided directly and reversed. Reversed statements are 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The total score of the expressions which are reversed from the total score of the direct expressions and adding the number 50 which is the constant value of the state anxiety scale. Spielberger and his colleagues stated that 0-19 points obtained from the scale meant "no anxiety", 20-39 points meant "light", 40-59 points meant "medium", 60-79 points meant "heavy anxiety".
Visual Analog Scale for pain intensity
Time frame: 10 minutes
After completing the HSG procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). Patients indicated the maximum pain intensity experienced during the HSG by making a vertical line on the VAS. A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.
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 18 Mar 2020.
- Background: PubMed 28720234Aba YA, Avci D, Guzel Y, Ozcelik SK, Gurtekin B. Effect of music therapy on the anxiety levels and pregnancy rate of women undergoing in vitro fertilization-embryo transfer: A randomized controlled trial. Appl Nurs Res. 2017 Aug;36:19-24. doi: 10.1016/j.apnr.2017.05.005. Epub 2017 May 22.
- Background: PubMed 29142446Onwuchekwa CR, Oriji VK. Hysterosalpingographic (HSG) Pattern of Infertility in Women of Reproductive Age. J Hum Reprod Sci. 2017 Jul-Sep;10(3):178-184. doi: 10.4103/jhrs.JHRS_121_16.
- Results publication: PubMed 26815804Stevenson EL, Hershberger PE, Bergh PA. Evidence-Based Care for Couples With Infertility. J Obstet Gynecol Neonatal Nurs. 2016 Jan-Feb;45(1):100-10; quiz e1-2. doi: 10.1016/j.jogn.2015.10.006. Epub 2015 Dec 1.
- Individual participant dataSharing planned: No
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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.
Gulten Guvenc principal investigator
University of Health Sciences, Gulhane Faculty of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Education and counseling in people with Women's Health, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 4 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 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Spielberger State Anxiety Scale (time frame: 30 minutes). 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 NCT03839147, which also lists 3 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 18 Mar 2020.