The Effect of Education and Counseling on Reducing Pain and Anxiety in Women Undergoing Hysterosalpingography

NCT ID: NCT03839147

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2017-01-01

Brief Summary

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.

Conditions

Women's Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Education and Counseling

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

Group Type: EXPERIMENTAL

Education and counseling

Intervention Type: BEHAVIORAL

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.

Control group

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 .

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education and counseling

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• being diagnosed with infertility
• negative the result of the B-HCG testing
• being able to understand, read and write in Turkish

Exclusion Criteria

• not wanting to be included in the study
• not accepting education/counseling
• not knowing Turkish
• having additional diseases related to pelvic pain

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gulten Guvenc

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences, Gulhane Faculty of Nursing

References

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.

Reference Type: BACKGROUND

PMID: 28720234 (View on PubMed)

Onwuchekwa 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.

Reference Type: BACKGROUND

PMID: 29142446 (View on PubMed)

Stevenson 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.

Reference Type: RESULT

PMID: 26815804 (View on PubMed)

Other Identifiers

50687469

Identifier Type: -

Identifier Source: org_study_id