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

NCT03839147 | Completed

• 1 other identifier: 50687469
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Women's Health

Keywords

hysterosalpingography; anxiety; pain; education; counseling

Outcome Measures

Primary Outcomes (2)

• 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".

  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.

  10 minutes

Study Arms (2)

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

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 .

Interventions

Education and counseling 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.

Education and Counseling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Related Publications (3)

• 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.

  PMID: 28720234 BACKGROUND

• 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.

  PMID: 29142446 BACKGROUND

• 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.

  PMID: 26815804 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Educational Status; Counseling

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gulten Guvenc

  University of Health Sciences, Gulhane Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 15, 2019
• Study Start: May 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 18, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share